--------------------------------------------------------------------------------------------------------------------------------------------------------
Korpela et al., 2006 (Ref. 37).....  Randomized double-      Mildly                  150 g low-fat yogurt,  Habitual diets plus    Total-C (mg/dL)
                                      blind, placebo-         hypercholesterolemic    50 g low-fat hard      low-fat yogurt and     Baseline:
                                      controlled, parallel    adults. 170 enrolled,   cheese, and 50 g low-  low-fat hard/fresh    C 247
                                      trial; 3-wk run-in, 6-  164 completed           fat fresh cheese       cheese                I 247
                                      wk test period         n = 82/group..........  C = yogurt and cheese                         % change compared to
                                                             Mean age     w/out added PS.                               control: I [darr]
                                                              sd.                    I= 1.65-2.0 g PS/d as                          6.5% (p < 0.05)
                                                             57  8 y      nonesterified sterol/                        LDL-C (mg/dL)
                                                              (C).                    stanol in enriched                            Baseline:
                                                             58  9 y      yogurt and cheeses.                          C 155
                                                              (I).                                                                 I 159
                                                             Inclusion criteria:                                                   % change compared to
                                                              Total-C 193-329 mg/                                                   control: I [darr]
                                                              dL, TG < 354 mg/dL.                                                   11.0% (p < 0.05)
                                                             Finland...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Jakulj et al., 2005 (Ref. 90)......  Randomized double-      Healthy moderately      25 g/d test margarine  Habitual diets.......  Total-C (mg/dL)
                                      blind, crossover        hypercholesterolemic    on sandwiches or                              Baseline: 261
                                      design for PS           adults 40 enrolled,     mixed with food in a                         At end of 4 wk test
                                      component, and open-    39 Included in          hot meal                                      period:
                                      label RX tmt; 2x2       analyses               C = spread w/o added                          C 249
                                      factorial trial. 2-wk  Mean age     PS.                                          I1 235
                                      run-in followed by      sd.                    I1 = 2.0 g PS/d as                            I2 208
                                      four consecutive 4-wk  55.5  7.9    plant sterol on PS-                          I3 204
                                      test periods            y.                      enriched spread.                             Total-C % change
                                                             n = 39................   Information not                               compared to control:
                                                             Inclusion criteria:      provided as to                               I1 [darr] 5.2%*
                                                              plasma LDL-C 135-193    whether                                      I2 [darr] 15.7%*
                                                              mg/dL; TG < 355 mg/dL.  nonesterified or                             I3 [darr] 17.2%*
                                                             The Netherlands.......   esterified.                                  *p < 0.05
                                                                                I2 = Ezetimibe.......                         LDL-C (mg/dL)
                                                                                I3 = Ezetimibe + PS-                           Baseline: 174
                                                                                enriched spread.                             At end of 4-wk:
                                                                                C 157
                                                                                I1 148
                                                                                I2 121
                                                                                I3 116
                                                                                % change compared to
                                                                                control:
                                                                                I1 [darr] 5.1%*
                                                                                I2 [darr] 20.9%*
                                                                                I3 [darr] 23.8%*
                                                                                *p < 0.05
--------------------------------------------------------------------------------------------------------------------------------------------------------

Clifton et al. 2004 (Ref. 88)......  Randomized single-      Mildly                  One serving/d each 4   Habitual diets         Total-C (mg/dL)
                                      blind, placebo-         hypercholesterolemic    of test foods          supplemented by one    Baseline: 241
                                      controlled,             adults 63 enrolled,     (bread, milk,          serving daily of      % change compared to
                                      incomplete crossover    58 completed            cereal, and yoghurt)   yoghurt, low-fat       placebo:
                                      trial; four            n = 58 (C)............   consumed with meals    milk, bread, and      I1 [darr] 5.6%*
                                      consecutive 3-wk test  n = 36 (I1)...........  C = test foods w/o      muesli-type cereal.   I2 [darr] 8.5%*
                                      periods, no washout    n = 40 (I2)...........   added PS.              No changes in         I3 [darr] 3.2%*
                                      periods                n = 58 (I3)...........  I1 = 1.6 g/d PS as      reported intakes of   I4 [darr] 6.3%*
                                                             n = 40 (I4)...........   soy sterol esters in   energy, fat, CHO, or  *p < 0.05
                                                             Mean age 54 y.........   2 slices of PS-        protein across        LDL-C (mg/dL)
                                                             Inclusion criteria:      enriched bread.        treatment periods or   Baseline: 156
                                                              BMI < 31, no RX that   I2 = 1.6 g/d PS as      between centers       % change compared to
                                                              affect lipids, total-   soy sterol esters in                          control:
                                                              C 193-290 mg/dL.        500 ml of 2% PS-                             I1 [darr] 10.4%*
                                                             Australia.............   enriched milk.                               I2 [darr] 13.2%*
                                                                                I3 = 1.6 g/d PS as                            I3 [darr] 6.0%*
                                                                                soy sterol esters in                         I4 [darr] 10.4%*
                                                                                45 g of PS-enriched                          *p < 0.05
                                                                                cereal.
                                                                                I4 = 1.6 g/d PS as
                                                                                soy sterol esters
                                                                                200g of PS-enriched
                                                                                yogurt.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Devaraj et al., 2004 (Ref. 33).....  Randomized double-      Healthy mildly          2 servings/d of test   Habitual diets. No     Total-C (mg/dL)
                                      blind, parallel trial   hypercholesterolemic    orange juice, with     other orange juice,    Baseline:
                                      with 2 groups; 2-wk     adults                  meals.                 citrus fruit, or PS-  C 209
                                      run-in period          75 enrolled; 72         C = orange juice w/o    enriched margarine    I 207
                                      followed by 8-wk test   completed.              added PS.              allowed. 3-day diet   Total-C % change
                                      period                 Mean age    I=2 g PS/d as           records at beginning   compared to control:
                                                              sd.                     nonesterified sterol   and end of study      I [darr] 5.3% (p <
                                                             44  13 y     in PS-enriched                                0.05)
                                                              (C).                    orange juice.                                LDL-C (mg/dL)
                                                             41  13 y                                                   Baseline:
                                                              (I).                                                                 C 140
                                                             n = 36/group..........                                                I 137
                                                             Inclusion criteria:                                                   LDL-C % change
                                                              LDL-C >100 mg/dL; no                                                  compared to control:
                                                              Rx that affect                                                        I [darr] 7.3% (p <
                                                              lipids, no smoking,                                                   0.05)
                                                              no HX of CVD.
                                                             USA...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thomsen et al., 2004 (Ref. 26).....  Randomized double-      Mildly                  2 servings/d of 1.2%-  Habitual Danish diet   Total-C (mg/dL)
                                      blind, crossover        hypercholesterolemic    fat test milk w/       with limits on         Baseline: 271
                                      trial, with three       adults                  meals                  certain fatty foods;  Total-C % change
                                      consecutive 4-wk       81 subjects Randomized  C = milk w/o added PS   e.g., 20 g/d cheese,   relative to control:
                                      periods; no run-in or   69 completed.          I1 = 1.2 g PS/day as    2 portions of         I1 [darr] 4.73%*
                                      wash-our periods       Mean age     nonesterified plant    crustaceans and       I2 [darr] 7.05%*
                                                              sd.                     sterols in PS-         mollusks per wk       * p < 0.0001
                                                             60  5 y...   enriched milk.                               LDL-C (mg/dL)
                                                             n = 69................  I2 = 1.6 g PS/day as                           Baseline: 169
                                                             Inclusion criteria: no   nonesterified plant                          LDL-C % change
                                                              RX that affect          sterols in PS-                                relative to control:
                                                              lipids, total-C 217-    enriched milk.                               I1 [darr] 7.1%*
                                                              325 mg/dL, TG < 310                                                  I2 [darr] 9.6%*
                                                              mg/dL.                                                               * p < 0.0001
                                                             Denmark...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cleghorn et al., 2003 (Ref. 91)....  Randomized double-      Mildly                  Test butter (20 g/d)   Self-selected low-fat  Total-C (mg/dL)
                                      blind, placebo-         hypercholesterolemic    or test margarine      diets. Test           At end of 3 wk test
                                      controlled, crossover   adults;                 (25 g/d)               substance (butter or   period:
                                      trial; 3-wk run-in     58 subjects enrolled,   B = Butter w/o added    margarine) added to   B 235
                                      period, 3-wk test       53 completed.           PS.                    low-fat diet          M 227
                                      period                 Mean age    M = margarine w/o                             I 215
                                                              sd.                     added PS.                                    Total-C % change
                                                             46.7  10.5  I = 2 g PS/d PS as                             relative to control:
                                                              y.                      plant sterol esters                           I [darr] 5.45% (p <
                                                             n = 53................   in PS-enriched                                0.05)
                                                             Inclusion criteria:      margarine.                                   LDL-C (mg/dL)
                                                              total-C 193-290 mg/                                                  At end of 3 wk test
                                                              dL, TG < 266 mg/dL;                                                   period:
                                                              no cholesterol-lowing                                                B 154
                                                              RX.                                                                  M 145
                                                             New Zealand...........                                                I 135
                                                                                LDL-C % change
                                                                                compared to control:
                                                                                I [darr] 7.2% (p <
                                                                                0.01)
--------------------------------------------------------------------------------------------------------------------------------------------------------

Homma et al., 2003 (Ref. 82).......  Randomized double-      Healthy adult Japanese  2 or 3 servings/d of   Habitual Japanese      Total-C (mg/dL)
                                      blind, placebo-        105 enrolled, 104        low-fat test spread,   diet. Diets were       Baseline:
                                      controlled, parallel    completed.              eaten w/meals.         assessed with 2 day   C 238
                                      trial, 4-wk test       Mean age    C = spread w/o added    diet analysis at      I1 235
                                      period, and 4-wk post-  sd.                     PS, 3 servings/d.      start and end of      I2 232
                                      trial follow-up        46  14 y    I1 = 2 g PS/d as        trial                 Total-C % change
                                      period                  (P).                    plant stanol esters                           compared to control:
                                                             47  13 y     in PS-enriched                               I1 [darr] 5.7%*
                                                              (I1).                   spread, 2 servings/d.                        I2 [darr] 4.9%*
                                                             49  12 y    I2 = 3 g PS/d as                              *p < 0.001
                                                              (I2).                   stanol esters in PS-                         LDL-C (mg/dL)
                                                             n = 33-34/group.......   enriched spread, 3                            Baseline:
                                                             Inclusion criteria:      servings/d.                                  C 157
                                                              age >20 y, total-C                                                   I1 153
                                                              209-278 mg/dL, TG <                                                  I2 153
                                                              345 mg/dL.                                                           LDL-C % change
                                                             Japan.................                                                 compared to control:
                                                                                I1 [darr] 8.9%*
                                                                                I2 [darr] 6.6%*
                                                                                *p < 0.001
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ishiwata et al., 2002 (Same          Randomized double-      See Homma et al. 2003   2 or 3 servings/d of   Habitual Japanese      Total-C (mg/dL)
 subjects as Homma et al., 2003)      blind, placebo-        n = 30-31/group.......   low-fat test spread,   diet                   Baseline:
 (Ref. 92).                           controlled, parallel   Analysis stratified by   eaten w/meals                                C ApoE3 236
                                      trial, 4-wk test        apolipoprotein E       C = spread w/o added                          C ApoE4 241
                                      period, and 4-wk post-  phenotype.              PS, 3 servings/d.                            I1 ApoE3 237
                                      trial follow-up                                I1 = 2 g PS/d as                              I1 ApoE4 231
                                      period                                          plant stanol esters                          I2 ApoE3 234
                                                                                in PS-enriched                               I2 ApoE4 233
                                                                                spread, 2 servings/d.                        Total-C % change
                                                                                I2 = 3 g PS/d as                               compared to control:
                                                                                stanol esters in PS-                         I1 ApoE3 [darr] 7.1%*
                                                                                enriched spread, 3                           I1 ApoE4 [darr] 6.3%*
                                                                                servings/d.                                  I2 ApoE3 [darr] 5.9%*
                                                                                I2 ApoE4 [darr] 4.7%
                                                                                * p < 0.05
                                                                                LDL-C (mg/dL)
                                                                                Baseline:
                                                                                C ApoE3 153
                                                                                C ApoE4 161
                                                                                I1 ApoE3 155
                                                                                I1 ApoE4 148
                                                                                I2 ApoE3 155
                                                                                I2 ApoE4 151
                                                                                LDL-C % change
                                                                                compared to control:
                                                                                I1 ApoE3 [darr] 9.2%*
                                                                                I1 ApoE4 [darr]
                                                                                11.0%*
                                                                                I2 ApoE3 [darr] 8.7%*
                                                                                I2 ApoE4 [darr] 6.4%
                                                                                * p < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
Jones et al., 2003 (Ref. 34).......  Randomized double-      Mildly                  3 servings/d of        Typical American       Total-C (mg/dL)
                                      blind, crossover        hypercholesterolemic    nonfat or low fat      diet. Controlled       Baseline:
                                      trial; three 3-wk       adults                  test beverage          intake; all food/     C 237
                                      controlled feeding     15 enrolled, 15          consumed w/meals       beverage prepared/    I1 242
                                      test periods            completed.             C = nonfat beverage w/  provided by study     I2 229
                                      separated by 4-wk      age range 22-68 y.....   o added PS.                                  Total-C % change at 3
                                      washout periods        n = 15................  I1 = 1.8 g PS/d as                             wk:
                                                             Inclusion criteria:      nonesterified plant                          C [darr] 8.5%
                                                              BMI 22-32 kg/m\2\,      tall oil sterol/                             I1 [darr] 11.6%
                                                              LDL-C 126-232 mg/dL,    stanol in PS-                                I2 [darr] 10.1%
                                                              HDL < 31 mg/dL, TG <    enriched nonfat                              no significant
                                                              355 mg/dL.              beverage.                                     differences between
                                                             Canada................  I2 = 1.8 g PS/d as                             control and PS
                                                                                nonesterified plant                           periods
                                                                                tall oil sterol/                             LDL-C (mg/dL)
                                                                                stanol in PS-                                 Baseline:
                                                                                enriched low fat                             C 155
                                                                                beverage.                                    I1 160
                                                                                I2 150
                                                                                LDL-C % change at 3
                                                                                wk:
                                                                                C [darr] 5.0%
                                                                                I1 [darr] 10.4%
                                                                                I2 [darr] 8.5%
                                                                                no significant
                                                                                differences between
                                                                                P and PS periods
--------------------------------------------------------------------------------------------------------------------------------------------------------

Naumann et al., 2003 (Ref. 42).....  Randomized double-      Healthy adults, 44      1 serving/d of test    Habitual diets; food   Total-C (mg/dL) At
                                      blind, placebo-         enrolled, 42            margarine              frequency              end of 3 wk:
                                      controlled, crossover   completed              C = margarine w/o       questionnaires        C 173
                                      trial; three           Mean age     added PS.              assessed diet at end  I1 167
                                      consecutive 3-wk test   sd.                    I1 = 2 g PS/d as        of each period. No    I2 168
                                      periods                32  14 y F   phytosterol ester,     margarine was         Total-C % difference
                                                             37  16 y M   1:1 sterol/stanol      allowed other than     compared to control:
                                                             n = 42................   ester ratio in PS-     the provided test     I1 [darr] 3.4%*
                                                             Inclusion criteria: BP   enriched margarine.    margarine. Study      I2 [darr] 2.7%*
                                                              < 160/95, BMI < 30,    I2 = 2 g PS/d as        provided sunflower    *p < 0.05
                                                              stable body wgt, age    phytosterol ester,     oil shortening (w/o   LDL-C (mg/dL)
                                                              18-65 y, Total-C <      3:1 sterol/stanol      added plant sterols   At end of 3 wk
                                                              309 mg/dL, TG < 355     ester ratio in PS-     and stanols) to       C 109
                                                              mg/dL.                  enriched margarine.    control unintended    I1 102
                                                             The Netherlands.......                          plant sterol and      I2 102
                                                                                stanol intake         LDL-C % difference
                                                                                compared to control
                                                                                3 wk:
                                                                                I1 [darr] 6.0%*
                                                                                I2 [darr] 6.7%*
                                                                                *p < 0.05
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qu[iacute]lez et al., 2003 (Ref.     Randomized double-      Healthy subjects, 61    2 test bakery          Habitual diets with    Total-C (mg/dL)
 93).                                 blind, placebo-         enrolled, 57 competed   products/d (1          test foods replacing   Baseline:
                                      controlled, parallel   Mean age     muffin, 1 croissant)   usual bakery product  C 162
                                      trial; 2 groups, 8 wk   sd.                     eaten at any time of   consumption           I 167
                                      test period            30.9  7.2    day                                          Total-C % change
                                                              y (C).                 C = bakery products w/                         compared to control:
                                                             31.0  6.7    o added PS.                                   I [darr] 8.9% (p <
                                                              y (I).                 I = 3.2 g PS/d as soy                          0.001)
                                                             n = 29 (C)............   sterol esters;                               Total-C (mg/dL)
                                                             n = 28 (I)............   divided between PS-                           Baseline:
                                                             Inclusion criteria:      enriched croissant                           C 93
                                                              BMI < 40, no RX or      and muffin.                                  I 97
                                                              diet that affect                                                     Total-C % change
                                                              blood lipids, total-C                                                 compared to control:
                                                              < 240 mg/dL, global                                                   I [darr] 14.6% (p <
                                                              CV risk < 20% (Eur                                                    0.001)
                                                              Soc for
                                                              Atherosclerosis
                                                              criteria), TG < 200
                                                              mg/dL, consumers of
                                                              bakery products.
                                                             Spain.................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seki et al., 2003 (Ref. 54)........  Randomized double-      Healthy mildly          3 slices test bread/d  Habitual diets; diets  Total-C (mg/dL)
                                      blind, parallel trial   hypercholesterolemic   C = bread made with     assessed with three    Baseline:
                                      with 2 groups; 2-wk     males                   veg oil w/o added PS.  3-d diet records      C 190
                                      run-in period          61 enrolled, 60         I = 0.45 g PS/d as                            I 194
                                      followed by 12-wk       completed.              plant sterol esters                          Total-C % change
                                      test period            Mean age     in PS-enriched veg                            compared to control:
                                                              sd.                     oil baked into bread.                         I [darr] 3%
                                                             39.4  1.4                                                 LDL-C (mg/dL)
                                                              y.                                                                    Baseline:
                                                             n = 28 (C)............                                                C 115
                                                             n = 32 (I)............                                                I 116
                                                             Inclusion criteria:                                                   LDL-C % change
                                                              healthy; total-C <                                                    compared to control:
                                                              280 mg/dL, TG < 400                                                   I [darr] 2.1%
                                                              mg/dL.                                                               No significant
                                                             Japan.................                                                 treatment effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Spilburg et al., 2003 (Ref. 27)....  Randomized double-      Moderately              Powdered lemonade-     American Heart         Total-C (mg/dL)
                                      blind, parallel         hypercholesterolemic    flavored fat-free      Association Step I     Baseline:
                                      trial, with 6-wk run-   adults                  test beverage, 3       diet; diet            C 200
                                      in period followed by  26 randomized, 24        servings/d             counseling to         I 224
                                      4-wk test period        completed.             P = beverage w/added    maintain weight if    % change compared to
                                                             Mean age     lecithin, w/o added    needed                 control: I [darr]
                                                              sd.                     PS.                                           10.1% (p < 0.05)
                                                             50.6  10 y  I = 1.9 g PS/d as                             LDL-C (mg/dL)
                                                             Inclusion criteria:      lecithin emulsified                          C 128
                                                              LDL-C 80-210 mg/dL,     soy nonesterified                            I 148
                                                              TG < 300; no illness;   stanol in PS-                                % change compared to
                                                              no RX except for oral   enriched beverage.                            control: I [darr]
                                                              contraceptives,                                                       14.3% (p < 0.05)
                                                              hormone replacement,
                                                              anti-hypertensives,
                                                              anti-depressants &
                                                              analgesics.
                                                             USA...................
--------------------------------------------------------------------------------------------------------------------------------------------------------

De Graaf et al., 2002 (Ref. 32)....  Randomized double-      Mildly                  3 servings/d of test   Self-selected Step I   Total-C (mg/dL)
                                      blind, parallel         hypercholesterolemic    chocolate/d (10.5 g    diet; supplemented w/ C 257
                                      trial; 4 wk run-in      adults                  each), eaten with      three servings/d of   I 261
                                      period; 4-wk test      70 randomized, 62        meals                  chocolate             Total-C% change
                                      period                  completed.             C = chocolate w/o                              compared to control:
                                                             Mean age..............   added PS.                                     I [darr] 6.4% (p <
                                                             57.8 y (C)............  I = 1.8 g PS/day as                            0.05)
                                                             56.2 y (I)............   nonesterified tall                           LDL-C (mg/dL)
                                                             n = 31/group..........   oil sterols/stanols                          C 177
                                                             Inclusion criteria:      in PS-enriched                               I 182
                                                              age 21-75 y; total-C    chocolate.                                   LDL-C% change
                                                              213-310 mg/dL, LDL-C                                                  compared to control:
                                                              >=135 mg/dL; TG < 354                                                 I [darr] 11.1 (p <
                                                              mg/dL; BMI < 35.                                                      0.05)
                                                             The Netherlands.......
--------------------------------------------------------------------------------------------------------------------------------------------------------
Geelen et al., 2002 (Ref. 94)......  Randomized double-      Healthy adults with     One tub (35 g) test    Habitual diets;        Total-C (mg/dL)
                                      blind, crossover        known apolipoprotein    margarine/d consumed   random 24-h recall     Baseline:
                                      trial, with 2           E phenotype 31 ApoE4    in place of usual      diet surveys          E3/4 & E4/4 201
                                      consecutive 3-wk test   subjects; 57 ApoE3      margarine              conducted during      E3/3 178
                                      periods                 subjects n = 88; Mean  C = margarine w/o       test                  Total-C% change
                                                              age 25.4 y              added PS.                                     compared to control:
                                                             Inclusion criteria:     I = 3.2 g PS/d as                              I [darr] 7% (p <
                                                              age >=18 y; no          vegetable oil sterol                          0.05)
                                                              prescribed diets; no    esters in PS-                                LDL-C% change
                                                              lipid-lowering RX;      enriched margarine.                           compared to control:
                                                              total-C <=310 mg/dL;                                                  I [darr] 11%
                                                              TG < 266 mg/dL.                                                       (P<0.05)
                                                             The Netherlands.......
--------------------------------------------------------------------------------------------------------------------------------------------------------
Judd et al., 2002 (Ref. 95)........  Randomized double-      Healthy adults, normal  Two servings/d of      Typical American       Type of salad
                                      blind, crossover        or slightly elevated    test salad dressing    diet; Controlled       dressing did not
                                      trial; two              total-C                 (Ranch or Italian),    diet provided by       affect plasma lipids
                                      consecutive 3-wk       58 enrolled, 53          eaten w/meals          study and eaten on     so data was combined
                                      intervention periods,   completed.             C1 = Ranch dressing w/  site                  Total-C (mg/dL)
                                      no wash out            Mean age     o added PS.                                   baseline: 214
                                                              sd.                    I1 = 2.2 g PS/d as                            Total-C% change
                                                             47.1  1.5    soy sterol esters in                          compared to control:
                                                              y.                      PS-enriched Ranch                             I [darr] 7.0% (p <
                                                             n = 53................   dressing.                                     0.0001)
                                                             Inclusion criteria:     C2 = Italian dressing                         LDL-C (mg/dL)
                                                              age 25-65 y; HDL >25    w/o added PS.                                 Baseline: 141
                                                              mg/dl (men) or >35 mg/ I2 = 2.2 g PS/d as                            LDL-C% change
                                                              dL (women), TG < 300    soy sterol esters in                          compared to control:
                                                              mg/dL.                  PS-enriched Italian                           I [darr] 9.2% (p <
                                                             USA...................   dressing.                                     0.0001)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Matvienko et al, 2002 (Ref. 60)....  Randomized double-      Hypercholesterolemic    One serving/d (112 g)  Habitual diets w/      Total-C (mg/dL)
                                      blind, placebo-         white males. 50% of     of cooked lean         limits on eggs (2-3    Baseline:
                                      controlled, parallel    subjects w/family HX    ground beef eaten at   eggs/wk), and no red  C 224
                                      trial; single 4-wk      of premature CVD &      lunch                  meat other than that  I 228
                                      test period             hyperlipidemia         C = ground beef......   in the test meal.     Total-C% change
                                                             36 enrolled, 34          w/o added PS........   Diets assessed by      compared to control:
                                                              completed.             I = 2.7 g PS/d as soy   interviewer            I [darr] 8.4% (p <
                                                             Mean age     sterols, partially     administered           0.001)
                                                              sd.                     esterified, in PS-     questionnaires        LDL-C (mg/dL)
                                                             22.23.9 y    enriched beef.                                Baseline:
                                                              (C).                                                                 C 153
                                                             23.63.9 y                                                 I 159
                                                              (I).                                                                 LDL-C% change
                                                             n = 17/group..........                                                 compared to control:
                                                             Inclusion criteria:                                                    I [darr] 13.3% (p <
                                                              total-C >197 mg/dL,                                                   0.001)
                                                              LDL-total-C >130 mg/
                                                              dL.
                                                             USA...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mensink et al., 2002 (Ref. 86).....  Randomized double-      Mildly                  3 servings/d of test   Habitual diets         Total-C (mg/dL)
                                      blind, placebo-         hypercholesterolemic    yogurt, eaten w/       supplemented with 3    Baseline:
                                      controlled, parallel    adults                  meals                  servings/day test     C 184
                                      trial; 3-wk run-in     69 randomized, 60       C = yogurt w/o added    yogurt. Low erucic    I 193
                                      followed by 4-wk test   completed.              PS.                    acid rapeseed oil     % change compared to
                                      period                 Mean age    I = 3 g PS/d as plant   margarine and          control: I [darr]
                                                              sd.                     stanol esters in PS-   shortening provided    8.7% (p < 0.001)
                                                             36  14 y..   enriched yogurt.       to standardize fatty  LDL-C (mg/dL)
                                                             n = 30/group..........                          acid intake. Diet      Baseline:
                                                             Inclusion criteria: no                          questionnaires to     C 111
                                                              diets that affects                             assess diet           I 113
                                                              lipids, no CAD HX,                                                   % change compared to
                                                              BMI < 30, total-C <                                                   control: I [darr]
                                                              251 mg/dL.                                                            13.7% (p < 0.001)
                                                             The Netherlands.......
--------------------------------------------------------------------------------------------------------------------------------------------------------

Mussner et al., 2002 (Ref. 96).....  Randomized double-      Mildly                  Two servings/d (10 g   Habitual diets; 3-day  Total-C (mg/dL)
                                      blind, crossover        hypercholesterolemic    each) of test          dietary recalls (at    Baseline: 233
                                      trial, with 2           adults                  margarine, consumed    beginning and end of  Total-C% change
                                      consecutive 3-wk test  63 enrolled, 62          in morning and         study) to assess       compared to control:
                                      periods                 completed.              evening, replacing     diets                  I [darr] 3.8% (p <
                                                             Mean age     usual margarine                               0.05)
                                                              sd.                    C = margarine w/o                             LDL-C (mg/dL)
                                                             42  11 y..   added PS.                                     Baseline: 152
                                                             n = 62................  I = 1.82 g PS/d as                            LDL-C% change
                                                             Inclusion criteria:      plant sterol esters                           compared to control:
                                                              BMI < 30, total-C 200-  in PS-enriched                                I [darr] 6.5% (p <
                                                              300 mg/dL, LDL-C 130-   margarine.                                    0.05)
                                                              200 mg/dL; TG < 160
                                                              mg/dL.
                                                             Germany...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Noakes et al., 2002 (Ref. 41)......  Randomized double-      Hypercholesterolemic    3 servings/d of        Usual low saturated    Total-C (mg/dL) After
                                      blind, crossover        adults                  reduced fat test       fat diet; w/>=5        3-wk intervention:
                                      trial; three           52 enrolled, 46          spread replacing       servings/d of fruit   C 244
                                      consecutive 3-wk test   completed.              usual margarine,       and vegetables, >=1   I1 229
                                      periods, no washout    Mean age     consumed w/meals       of which was high in  I2 226
                                      period; 1-wk run-in     sd.                    C = spread w/o added    carotenoids           Total-C% change
                                     Study 1...............  55  9.7 y    PS.                                           compared to control:
                                                              M.                     I1 = 2.3 g PS/d as                            I1 [darr] 6.0%*
                                                             58  7.3 y    plant sterol esters                          I2 [darr] 7.3%*
                                                              F.                      in PS-enriched                               *p < 0.001
                                                             n = 46................   spread.                                      LDL-C (mg/dL) After 3-
                                                             Inclusion criteria:     I2 = 2.5 g PS/d as                             wk intervention:
                                                              age 20-75 y; BMI <      plant stanol esters                          C 166
                                                              31, no RX that affect   in PS-enriched                               I1 153
                                                              lipids, total-C 209-    spread.                                      I2 150
                                                              329 mg/dL, TG < 400                                                  LDL-C% change
                                                              mg/dL.                                                                compared to control:
                                                             The Netherlands.......                                                I1 [darr] 7.7%*
                                                                                I2 [darr] 9.5%*
                                                                                *p < 0.001
                                                                                No significant
                                                                                difference between
                                                                                I1 and I2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Randomized double-      Hypercholesterolemic    3 servings/d of        Diet same as in Study  Total-C (mg/dL) After
                                      blind, crossover        adults                  reduced fat test       1             3-wk intervention:
                                      trial; two             40 enrolled, 35          spread replacing                             C 233
                                      consecutive 3-wk test   completed.              usual margarine,                             I3 218
                                      periods, no washout    n = 35................   consumed w/meals                             Total-C% change
                                      period; 1-wk run-in    Inclusion criteria:     C = spread w/o added                           compared to control:
                                     Study 2...............   BMI < 31, no RX that    PS.                                           I3 [darr] 6.6%*
                                                              affect lipids, total-  I3 = 2 g PS/d as                              LDL-C (mg/dL) After 3-
                                                              C 209-329 mg/dL, TG <   plant sterol esters                           wk intervention:
                                                              400 mg/dL.              in PS-enriched                               C 161
                                                             The Netherlands.......   spread.                                      I3 145
                                                                                LDL-C% change
                                                                                compared to control:
                                                                                I3 [darr] 9.6%*
                                                                                *p < 0.001
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ntanios et al., 2002 (Ref. 97).....  Double-blind, placebo-  Healthy adult           Two servings/d low-    Habitual Japanese      Total-C (mg/dL) After
                                      controlled, crossover   Japanese, 53            fat test spread        diet. Diets assessed   3 wks of
                                      trial. 1-wk run-in;     enrolled, 53            consumed w/meals       with food frequency    intervention:
                                      Two consecutive 3-wk    completed              C = spread w/o added    questionnaire during  C 213
                                      test periods w/o wash- Mean age     PS.                    run-in period         I 201
                                      out period              sd.                    I = 1.8 g PS/d as                             Total-C% change
                                                             45.1  10.4   plant sterol esters                           compared to control:
                                                              y.                      in PS-enriched                                I [darr] 5.8% (p <
                                                             n = 53................   spread.                                       0.01)
                                                             Inclusion criteria:                                                   LDL-C (mg/dL) After 3
                                                              age 24-67 y; BMI 19-                                                  wks of intervention
                                                              30, healthy, normal                                                  C 119
                                                              diet, no HX of CVD or                                                I 109
                                                              [uarr] total-C.                                                      LDL-C% change
                                                             Japan.................                                                 compared to control:
                                                                                I [darr] 9.1% (p <
                                                                                0.001)
--------------------------------------------------------------------------------------------------------------------------------------------------------

Simons et al., 2002 (Ref. 98)......  Multicenter,            Hypercholesterolemic    Two servings/d of      American Heart         Total-C (mg/dL)
                                      randomized double-      adults, some using      test margarine,        Association Step I     Baseline:
                                      blind, placebo-         statin drugs            consumed w/meals.      diet; closely         I1 295
                                      controlled, parallel   154 enrolled, 152        Drug intervention:     supervised by a       I2 297
                                      2 X 2 factorial trial   completed.              400 [mu]g/day          nutritionist          I3 282
                                      with 4-wk test period  Mean age     cerivastatin, or                             I4 298
                                                              sd.                     placebo tablet                               Total-C% change at 4
                                                             60  9 y     I1 = tablet +                                  wk relative to
                                                              (I1).                   margarine.                                    baseline:
                                                             58  10 y    I2 = placebo tablet +                         I1 [uarr]2.2%
                                                              (I2).                   2 g PS/d as plant                            I2 [darr] 5.3%
                                                             58  11 y     sterol esters in PS-                         I3 [darr] 23.2%
                                                              (I3).                   enriched margarine.                          I4 [darr] 28.9%
                                                             62  11 y    I3 = statin + placebo                         Main effect of PS-
                                                              (I4).                   margarine.                                    enriched margarine:
                                                             n = 37-29/group.......  I4 = statin + 2 g PS/                          [darr] 6.7% (p <
                                                             Inclusion criteria:      d as plant sterol                             0.0001)
                                                              LDL-C >=97 mg/dL, TG    esters in PS-                                LDL-C (mg/dL)
                                                              < 400 mg/dL, age >18    enriched margarine.                           Baseline:
                                                              y.                                                                   I1 210
                                                             Australia.............                                                I2 209
                                                                                I3 195
                                                                                I4 209
                                                                                LDL-C% change at 4 wk
                                                                                compared to
                                                                                baseline:
                                                                                I1 [uarr]2%
                                                                                I2 [darr] 8.2%
                                                                                I3 [darr] 32.4%
                                                                                I4 [darr] 38.5%
                                                                                Main effect of PS-
                                                                                enriched margarine:
                                                                                [darr] 8.1% (p <
                                                                                0.0001)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tammi et al., 2002 (Ref. 99).......  Randomized double-      Healthy children (age   20 g/d test margarine  Continuation of STRIP  Total-C (mg/dL)
                                      blind, crossover        6 y) enrolled in        replaced similar       study diet (low sat    Baseline:
                                      trial, with two 3       Finnish STRIP* study    amount of usual        fat, low              158 (boys)
                                      month test periods     81 enrolled, 79          dietary fat            cholesterol) that     176 (girls)
                                      separated by a 6-wk     completed.             C = margarine w/o       the subjects had      Total-C% change at 3-
                                      wash out period        n = 35 F..............   added PS.              followed for several   mo compared to
                                                             n = 44 M..............  I = 1.6 g PS/d as       years                  control
                                                             *Special Turku           plant stanol esters                          Iboys [darr] 6.4%*
                                                              Coronary Risk Factor    in PS-enriched                               Igirls [darr] 4.4%*
                                                              Project; subjects       margarine.                                   *p < 0.05
                                                              enrolled as infants;                                                 LDL-C (mg/dL)
                                                              study diet aim was                                                    Baseline:
                                                              1:1:1 ratio of                                                       98 (boys)
                                                              PUFA:MUFA:sat fats,                                                  123 (girls)
                                                              cholesterol < 200 mg/                                                LDL-C% change at 3-mo
                                                              d.                                                                    compared to control:
                                                                                Iboys [darr] 9.1%*
                                                                                Igirls [darr] 5.8%*
                                                                                *p < 0.05
--------------------------------------------------------------------------------------------------------------------------------------------------------
Temme et al., 2002 (Ref. 100)......  Randomized double-      Healthy adults, 42      3 portions/d of test   Habitual diet........  Total-C (mg/dL) After
                                      blind, crossover        enrolled, 42            margarine eaten w/                            4 wk test period:
                                      trial; no run-in        completed               meals replaced                               C 248
                                      period; two            Mean age     habitual margarine                           I 231
                                      consecutive 4-wk test   sd.                     use                                          Total-C% change
                                      periods                55  9 y...  C = spread w/o added                           compared to control:
                                                             n = 42................   PS.                                           I [darr] 6.9%*
                                                             Inclusion criteria:     I = 2.1 g PS/d as                             LDL-C (mg/dL) After 4
                                                              BMI < 30, no RX or      plant sterol esters                           wk test period:
                                                              prescribed diet that    in PS-enriched                               C 166
                                                              affect lipids.          spread.                                      I 150
                                                             Report states 70% of                                                  LDL-C % change
                                                              Belgium adult                                                         compared to control:
                                                              population is mildly                                                  I [darr] 9.6%*
                                                              hypercholesterolemic.                                                *p < 0.05
                                                             Belgium...............
--------------------------------------------------------------------------------------------------------------------------------------------------------

Vanstone et al., 2002 (Ref. 22)....  Randomized double-      Primary familial        3 portions/d test      Controlled feeding of  Total-C (mg/dL) At
                                      blind, crossover        hyperlipidemia adults   butter eaten w/meals   typical American       end of 3 wk test
                                      trial; no run-in       16 enrolled, 15         C = butter w/           diet, all food and     period:
                                      period; four 3-wk       completed.              cornstarch added to    beverage prepared/    C 238
                                      controlled test        Mean age     mimic appearance of    provided by study, 2  I1 214
                                      periods separated by    sd.                     PS-enriched butter.    or more meals/d       I2 215
                                      4-wk washout periods   47.8  1.9   I1 =1.8 g PS/d as       eaten onsite          I3 216
                                                              y.                      nonesterified soy                            Total-C % change
                                                             n = 15................   sterols in PS-                                compared to control:
                                                             Inclusion criteria:      enriched butter.                             I1 [darr] 7.8%*
                                                              age 35-58 y; Total-C   I2 = 1.8 g PS/d as                            I2 [darr] 11.9%*
                                                              201-348 mg/dL, and TG   nonesterified soy                            I3 [darr] 13.1%*
                                                              < 310 mg/dL.            stanols in PS-                               LDL-C (mg/dL) At end
                                                             Canada................   enriched butter.                              of three wk test
                                                                                I3 = 1.8 g PS/d as 50/                         period:
                                                                                50 mix of                                    C 155
                                                                                nonesterified soy                            I1 139
                                                                                sterols/stanols in                           I2 139
                                                                                PS-enriched butter.                          I3 137
                                                                                LDL-C % change at 3
                                                                                wk relative to
                                                                                placebo:
                                                                                I1[darr]11.3*
                                                                                I2[darr]13.4*
                                                                                I3[darr]16.0*
                                                                                *p < 0.05
                                                                                No significant
                                                                                difference between
                                                                                I1, I2 and I3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Christiansen et al., 2001 (Ref. 24)  Randomized double-      Hypercholesterolemic    2 servings/d of test   Habitual Finnish       Total-C (mg/dL)
                                      blind, parallel         adults                  spread (rapeseed oil   diet; 7-day food       Baseline: 257
                                      design; three arm, 6-  155 enrolled, 134        margarine) in place    diaries ``were kept   Total-C % change
                                      wk run-in, 6-month      completed.              of usual dietary fat   by half of             compared to control:
                                      test period            Mean age 50.7 y.......  C = spread w/o added    subjects.''           I1 [darr] 9%*
                                                             n = about 45/group....   PS.                                          I2 [darr] 8.3%*
                                                             Inclusion criteria:     I1 = 1.5g PS/d as                             *p=0.001
                                                              total-C >= 227 mg/dL,   microcrystalline                             LDL-C (mg/dL)
                                                              TG < 266 mg/dL.         wood-derived (tall                            Baseline: 166
                                                             Finland...............   oil) nonesterified                           LDL-C % change
                                                                                sterol/stanols in PS-                         compared to control:
                                                                                enriched spread.                             I1 [darr] 11.3%*
                                                                                I2 = 3 g PS/d as                              I2 [darr] 10.6%*
                                                                                microcrystalline                             *p=0.002
                                                                                wood-derived (tall
                                                                                oil) nonesterified
                                                                                sterol/stanols in PS-
                                                                                enriched spread.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Davidson et al., 2001 (Ref. 55)....  Randomized double-      Healthy adults          2 servings/d of        Habitual diet          Total-C (mg/dL)
                                      blind, parallel        84 randomized 77         reduced- fat test      supplemented w/3       Baseline: 205
                                      trial; four arm, 8-wk   completed.              spread, and 1          servings/d of test    Total-C % change
                                      test period            Mean Age 46 y.........   serving/d of reduced-  foods. 3-day diet      compared to control:
                                                             n = 19 (C)............   fat test salad         records collected at  I1 [darr] 3.9%
                                                             n = 19 (I1)...........   dressing               wk 0, 4, and 8        I2 [darr] 0.9%
                                                             n = 18 (I2)...........  C = spread + salad                            I3 [darr] 4.6%
                                                             n = 21 (I3)...........   dressing.                                    LDL-C (mg/dL)
                                                             Inclusion criteria:     I1 = 3 g PS/d as                               Baseline: 130
                                                              total-C < 300 mg/dL,    sterol esters in PS-                         LDL-C % change
                                                              TG < 350 mg/dL, BMI <   enriched spread;                              compared to control:
                                                              35.                     placebo salad                                C [darr] 1.3%
                                                             USA...................   dressing.                                    I1 [darr] 3.7%
                                                                                I2 = 6 g PS/d as                              I2 [darr] 1.5%
                                                                                sterol esters in PS-                         I3 [darr] 7.7%
                                                                                enriched salad                               No significant
                                                                                dressing; placebo                             treatment effects on
                                                                                spread.                                       total-C or LDL-C
                                                                                I3 = 9 g PS/d as
                                                                                sterol esters in PS-
                                                                                enriched spread + PS-
                                                                                enriched salad
                                                                                dressing.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Maki et al., 2001 (Ref. 101).......  Randomized double-      Hypercholesterolemic    2 servings/d of        National Cholesterol   Total-C (mg/dL)
                                      blind, placebo-         adults                  reduced-fat test       Education Program      Baseline: 238
                                      controlled, parallel   224 enrolled, 192        spread eaten w/meals   Step I, supplemented  Total-C % change
                                      trial, 4-wk run-in; 5-  included in analysis.  C = spread with w/o     w/reduced-fat test     compared to control:
                                      wk test period         n = 83 (C)............   added PS.              spread                I1 [darr] 5.2%*
                                                             n = 75 (I1)...........  I1 = 1.1 g PS/d as                            I2 - 6.6%*
                                                             n = 35 (I2)...........   soy sterol esters in                         *p < 0.001
                                                             Mean age     PS-enriched spread.                          LDL-C (mg/dL)
                                                              sd.                    I2 = 2.2 g PS/d as                             Baseline: 158
                                                             57.5  10.8   soy sterol esters in                         LDL-C % change
                                                              y (C).                  PS-enriched spread.                           compared to control:
                                                             58.7  10.6                                                I1 [darr] 7.6%*
                                                              y (I1).                                                              I2 [darr] 8.1%*
                                                             60.4  9.7                                                 *p < 0.001
                                                              y (I2).
                                                             Inclusion criteria: no
                                                              RX that affect
                                                              lipids, BMI < 35, LDL-
                                                              C 130-200 mg/dL, TG <
                                                              350 mg/dL, BMI < 35.
                                                             USA...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nestel et al., 2001 (Ref. 35)......  Randomized single-      Hypercholesterolemic    3 servings/d of test   Habitual low sat fat,  Median Total-C (mg/
                                      blinded, crossover      adults                  foods (low-fat wheat   low cholesterol diet   dL) at 4 wk:
                                      trial; 2-wk run-in,    22 enrolled, 22          cereal, low-fat        prescribed for        C 271
                                      three 4-wk test         completed.              bread, spread), one    cholesterol control;  I1 247*
                                      periods w/o wash-out   Mean age     serving eaten w/each   diet assessed by 3-   I2 261*
                                      period                  sd.                     meal                   day FFQ during run-   *p < 0.001 compared
                                     Study 1...............  60  9 y...  C = test foods, w/o     in phase               to control
                                                             n = 22................   added phytosterols.                          Median LDL-C (mg/dL)
                                                             Inclusion criteria:     I1 = 2.4 g PS/d as                             at 4 wk:
                                                              Total-C >213 mg/dL,     soy sterol esters in                         C 184
                                                              TG < 266 mg/dL.         PS-enriched foods.                           I1 159*
                                                             Australia.............  I2 = 2.4 g PS/d as                            I2 169*
                                                                                nonesterified soy                            *p < 0.05 compared to
                                                                                stanols in PS-                                control
                                                                                enriched foods.                              I1 significantly
                                                                                lower than I2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Randomized single-      Hypercholesterolemic    1 serving/d of test    Habitual low sat fat,  Total-C (mg/dL)
                                      blinded, crossover      adults (all Study 1     dairy spread (butter   low cholesterol diet   Baseline: 257
                                      trial; 2-wk run-in      participants)           + margarine blend)     prescribed for        Total-C % change
                                      followed by two 4-wk   15 enrolled, 15          eaten w/a meal         cholesterol control    compared to control:
                                      test periods w/o wash-  completed.             C = spread w/o added                           I3 [darr] 9.8%*
                                      out period             Australia.............   PS.                                          *p < 0.001
                                     Study 2...............                          I3 = 2.4 g PS/d as                            LDL-C (mg/dL)
                                                                                soy sterol esters in                          Baseline: 178
                                                                                PS-enriched dairy                            LDL-C % change
                                                                                spread.                                       compared to control:
                                                                                I3 [darr] 13.0%*
                                                                                *p = 0.05
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tikkanen 2001 (Ref. 25)............  Double-blind, placebo-  Hypercholesterolemic    3 servings/d of test   Subjects received      Total-C (mg/dL)
                                      controlled, parallel    adults                  foods/d (bread,        individual dietary     Baseline:
                                      trial, two arms; 2-wk  78 enrolled, 71          meat, jam)             advice and kept 3-d   C 253
                                      run-in period w/        completed.             C = test foods w/o      food diaries 5 times  I 263
                                      placebo foods, 3       Mean age     added PS.              during the study      Total-C % change
                                      consecutive 5-wk        sd.                    I=1.25 g PS/d for 5                            compared to control:
                                      periods. PS dose       54  11 y     wk, then 2.5 g PS/d                          I wk5 [darr] 4.4%
                                      doubled w/each          (C).                    for wks 6-10, then 5                         I wk10 [darr] 6.2%
                                      successive test        57  8 y      g PS/d for wks 11-                           I wk15 [darr] 5.5%
                                      period                  (I).                    15. PS as                                    Significant
                                                             n = 35 (C)............   nonesterified wood-                           difference between P
                                                             n = 36 (I)............   derived sterol/                               and I by repeated
                                                             Inclusion criteria:      stanol mixture in PS-                         measures ANOVA p <
                                                              age 25-75 y; no         enriched bread,                               0.05
                                                              familial [uarr]total-   meats, and jam.                              LDL-C (mg/dL)
                                                              C, no HX of CAD                                                       Baseline:
                                                              previous 3 mos, no HX                                                C 166
                                                              of revascularization                                                 I 173
                                                              previous 4 mo, no RX                                                 LDL-C % change
                                                              that affect lipids,                                                   compared to control:
                                                              total-C 232-310 mg/                                                  I wk5 [darr] 5.4%
                                                              dL; TG < 355 mg/dL.                                                  I wk10 [darr] 7.9%
                                                             Finland...............                                                I wk15 [darr] 8.9%
                                                                                Significant
                                                                                difference between C
                                                                                and I by repeated
                                                                                measures ANOVA p <
                                                                                0.05
--------------------------------------------------------------------------------------------------------------------------------------------------------

Blair et al., 2000 (Ref. 102)......  Randomized double-      Hypercholesterolemic    3 servings/d of test   Habitual diet. Diets   Total-C (mg/dL)
                                      blind, placebo-         adults on statin RX     margarine in place     assessed by 24-hr      Baseline: 231
                                      controlled, parallel   167 randomized, 141      of usual margarine     recalls               Total-C % change
                                      trial, two arms; 8-wk   completed.              consumptions                                  compared to control:
                                      test period with       Mean age    C = margarine w/o                              I [darr] 7% (p <
                                      additional 6-wk         sd.                     added PS.                                     0.0001)
                                      follow-up              56  10 y..  I = 3.0g PS/d as                              LDL-C (mg/dL)
                                                             n = 72 (C)............   stanol esters in PS-                          Baseline: 147
                                                             n = 69 (I)............   enriched margarine.                          LDL-C % change
                                                             Inclusion criteria:                                                    compared to control:
                                                              age >=20 y; LDL-C                                                     I [darr] 9.6% (p <
                                                              >=130 mg/dL, TG <=350                                                 0.0001)
                                                              mg/dL, stable statin
                                                              dose for >90d.
                                                             USA...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hallikainen et al., 2000B (Ref. 39)  Randomized double-      Mildly                  2-3 portions/d of      Step I diet. Diet was  Total-C (mg/dL) At
                                      blind, crossover        hypercholesterolemic    test margarines        assessed with 4-day    end of 4 wk:
                                      trial; 2-wk run-in      adults                  eaten with meals       food records at the   C 236
                                      period; three          42 enrolled, 34         C = margarine w/o       end of each period    I1 213
                                      consecutive 4-wk test   completed.              added PS.                                    I2 218
                                      periods                Mean age    I1 = 2 g PS/d as                              Total-C % change
                                                              sd.                     plant stanol ester                            compared to control:
                                                             48.8  8.1    in PS-enriched                               I1 [darr] 9.2%*
                                                              y.                      margarine.                                   I2 [darr] 7.3%*
                                                             n = 34................  I2 = 2 g PS/d as                              *p < 0.001
                                                             Inclusion criteria:      plant sterol ester                           LDL-C (mg/dL) At end
                                                              age 30-65 y, Total-C    in PS-enriched                                of 4 wk:
                                                              186-271 mg/dL, TG <     margarine.                                   C 162
                                                              220 mg/dL.                                                           I1 141
                                                             Finland...............                                                I2 145
                                                                                LDL-C % change
                                                                                compared to control:
                                                                                I1 [darr] 12.7%*
                                                                                I2 [darr] 10.4%*
                                                                                *p < 0.001
                                                                                I1 and I2 not
                                                                                significantly
                                                                                different
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hallikainen et al., 2000a (Ref. 53)  Randomized single-      Hypercholsterolemic     2-3 portions of test   Subjects consumed a    Total-C (mg/dL)
                                      blind crossover         adults                  margarine w/meals      standardized           Baseline:
                                      trial; 1-wk run-in     22 entolled, 22         C = margarine w/out     background diet       266  50
                                      period, five 3-wk       completed.              added PS.                                     mg/dL0
                                      test periods           Mean age 50.5  11.7.            plant stanol esters.                          compared to control:
                                                             n = 22................  I2 = 1.6 g/d PS/d as                          I1 [darr] 2.8%
                                                             Inclusion criteria:      plant stanol esters.                         I2 [darr] 6.8%*
                                                              Total-C 194-329 mg/dL. I3 = 2.4 g PS/d as                            I3 [darr] 10.3%*
                                                             Finland...............   plant stanol esters.                         I4 [darr] 11.3%*
                                                                                I4 = 3.2 g PD/d as                            LDL-C % change
                                                                                plant stanol esters.                          compared to control:
                                                                                I1 [darr] 1.7%
                                                                                I2 [darr] 5.6%
                                                                                I3 [darr] 9.7%*
                                                                                I4 [darr] 10.4%*
                                                                                *p < 0.05
--------------------------------------------------------------------------------------------------------------------------------------------------------
Jones et al., 2000 (Ref. 40).......  Randomized double-      Hyperlipidemic males    3 servings/d of test   Controlled diet        Total-C (mg/dL)
                                      blind, crossover       18 enrolled, 15          margarine, eaten       formulated to meet     Baseline:
                                      trial; no run-in        included in analyses.   with meals             Canadian Recommended  C 250
                                      period; three 3-wk     n = 15................  C = margarine w/o       Nutrient Intakes.     I1 247
                                      controlled feeding     Inclusion criteria:      added PS.              All food and          I2 246
                                      test periods            Age 37-61 y; Total-C   I1 = 1.84 g PS/d as     beverage prepared/    Total-C % change
                                      separated by 5-wk       232-387 mg/dL, TG <     plant sterol esters    provided by study;     compared to control:
                                      washout periods         266 mg/dL.              in PS-enriched         at least 2 meals/d    I1 [darr] 9.1%*
                                                             Canada................   margarine.             eaten onsite          I2 [darr] 5.5%
                                                                                I2 = 1.84 g PS/d as                           *p < 0.02
                                                                                plant stanol esters                          LDL-C (mg/dL)
                                                                                in PS-enriched                                Baseline:
                                                                                margarine.                                   C 172
                                                                                I1 166
                                                                                I2 168
                                                                                LDL-C % change
                                                                                compared to control:
                                                                                I1 [darr] 13.2%*
                                                                                I2 [darr] 6.4%* *
                                                                                *p < 0.02
                                                                                I1 significantly
                                                                                lower than I2
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Plat et al. 2000 (Ref. 87).........  Randomized double-      Healthy, normal or      One serving/d of test  Habitual diets         Total-C (mg/dL)
                                      blind, placebo-         mildly                  margarine and 3        supplemented w/test   At end of 4 wk:
                                      controlled, crossover   hypercholesterolemic    servings/d of test     margarine and test    C 194
                                      trial. Three            subjects                shortening (in         cookies/cake. PS-     I1 182
                                      consecutive 4-wk test  40 enrolled, 39          cookies/cakes) with    free shortening was   I2 181
                                      periods, no washout     completed.              each meals             provided to subjects  Total-C % change
                                      periods                Mean age    C = margarine &         for baking and         compared to control:
                                                              sd.                     shortening w/o added   cooking               I1 [darr] 6.4%*
                                                             31  14 y..   PS.                                          I2 [darr] 6.6%*
                                                             n = 39................  I1 = 2.5 g PS/d as                            *p < 0.001
                                                             Inclusion criteria:      stanol ester in PS-                          LDL-C (mg/dL) At end
                                                              age 18-65 y; Total-C    enriched margarine                            of 4 wk
                                                              < 250 mg/dL; TG <       eaten w/lunch.                               C 118
                                                              266; BMI < 30, BP <    I2 = 2.5 g PS/d as                            I1 106
                                                              160/95, no RX or diet   stanol ester in PS-                          I2 106
                                                              that affect lipids,     enriched margarine                           LDL-C % change
                                                              no HX of CVD.           and PS-enriched                               compared to control:
                                                             The Netherlands.......   shortening divided                           I1 [darr] 9.9%*
                                                                                over 3 servings w/                           I2 [darr] 10.2%*
                                                                                meals.                                       *p < 0.001
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Vissers et al., 2000 (Ref. 36).....  Double-blind,           Normal adults           Test margarine,        Habitual diets. Diet   Total-C (mg/dL) At
                                      crossover trial; no    60 enrolled, 60          divided over           assessed each period   end of 3 wks:
                                      run-in period; three    completed.              multiple portions,     with 24-h diet        C 164
                                      consecutive 3-wk test  age range=18-59 y.....   eaten with meals in    recall                I1 157
                                      periods                n = 60................   place of usual                               I2 162
                                                             Inclusion criteria:      margarine                                    Total-C % change
                                                              age >17 y; no RX or    C = margarine without                          compared to control:
                                                              prescribed diet that    added PS.                                    I1 [darr] 4.5%*
                                                              affect lipids, Total-  I1 = 2.1 g PS/d as                            I2 [darr] 1.2%
                                                              C < 290 mg/dL, TG <     rice bran                                    *p < 0.05
                                                              204 mg/dL.              nonesterified oil                            LDL-C (mg/dL) At end
                                                             The Netherlands.......   sterols in PS-                                of 3 wks:
                                                                                enriched margarine                           C 91
                                                                                (~1 g/d of 4-                                I1 84
                                                                                desmethylsterols).                           I2 89
                                                                                I2 = sheanut oil                              LDL-C % change
                                                                                triterpenes in                                compared to control:
                                                                                margarine.                                   I1 [darr] 8.5%*
                                                                                I2 [darr] 3.0%
                                                                                *p < 0.05
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Andersson et al., 1999 (Ref. 103)..  Randomized double       Moderately              25 g/d margarine       Consumed a test diet.  Total-C % change
                                      blind controlled        hypercholesterolemic    provided as 3 single                          compared to baseline
                                      parallel trial; 4-wk    adults                  servings                                     C [darr] 8.0%
                                      run-in period, three   Age  sd...  C = margarine w/o                             I1 [darr] 15%*
                                      8-wk test periods      55.1  7.9    added PS.                                    *p = 0.0035
                                                              y.                     I1 = 2 g PS/d as                              LDL-C % change
                                                             n = 21 (C)............   plant stanol esters                           compared to baseline
                                                             n = 19 (I)............   in PS-enriched                               C [darr] 12%
                                                             Inclusion criteria:      margarine.                                   I1 [darr] 19%*
                                                              Total-C < 330 mg/dL,                                                 *p = 0.0158
                                                              BMI >30.
                                                             Sweden................
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Ayesh et al., 1999 (Ref. 104)......  Randomized placebo-     Healthy adults          40 g/d margarine       Typical British diet,  Total-C % change
                                      controlled parallel    24 enrolled, 21          consumed at            breakfast and dinner   compared to control:
                                      trial; 21 to 28 d run-  completed.              breakfast and dinner   consumed under        I [darr] 18%*
                                      in, 21-28 d test       Age 30-40 y...........  C = margarine w/o       supervision           LDL-C % change
                                      period                 n = 11 (C)............   added PS.                                     compared to control:
                                                             n =10 (I).............  I = 8.6 g PS/d as                             I [darr] 23%*
                                                             Inclusion criteria:      plant sterol esters                          *p < 0.0001
                                                              Total-C 158-255 mg/dL.  in PS-enriched
                                                             United Kingdom........   margarine.
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Gylling and Miettinen, 1999 (Ref.    Randomized double-      Moderately              25 g/d butter          Subjects were advised  Total-C % change
 105).                                blind crossover         hypercholesterolemic,  C = butter w/out        to replace 25 g of     compared to control:
                                      trial; 1-wk run-in      postmenopausal women;   added PS.              their normal dietary  I [darr] 8%*
                                      period; two 5 wk test   24 enrolled            I = 2.4 g PS/d as       fat with butter       LDL-C % change
                                      periods                Age 50-55 y...........   wood sitostanol                               compared to control:
                                                             n = 21 butter period..   ester in PS-enriched                         I [darr] 12%*
                                                             Inclusion criteria:      butter.                                      *p < 0.05
                                                              Total-C between 213
                                                              and 310 mg/dL.
                                                             Finland...............
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Hendriks et al., 1999 (Ref. 51)....  Randomized, double-     Normocholesterolemic    25 g/d butter or       Habitual diets.        Total-C (mg/dL)
                                      blind, crossover        and mildly              spread consumed at     Spreads replace an     Baseline:
                                      trial; no run-in        cholesterolemic         lunch or dinner        equivalent amount of  197 mg/dL
                                      period, four test       adults, 100 enrolled,  C1 = butter w/out       spreads habitually    Total-C % change
                                      periods of 3.5 wks      80 per test period      added PS.              used                   compared to C2
                                                             Age 19-58 y...........  C2 = spread w/out                             I1 [darr] 4.9%*
                                                             n = 80................   added PS.                                    I2 [darr] 5.9%*
                                                             Inclusion criteria:     I1 = 0.8 g PS/d as                            I3 [darr] 6.8%*
                                                              Total-C < 290 mg/dL.    plant sterol esters                          LDL-C % change
                                                             The Netherlands.......   in PS-enriched                                compared to C2
                                                                                spreads.                                     I1 [darr] 6.7%*
                                                                                I2 = 1.6 g PS/d as                            I2 [darr] 8.5%*
                                                                                plant sterol esters                          I3 [darr] 9.9%*
                                                                                in PS-enriched                               *p < 0.0001
                                                                                spreads.
                                                                                I3 = 3.2 g PS/d as
                                                                                plant sterol esters
                                                                                in PS-enriched
                                                                                spreads.
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Jones et al., 1999 (Ref. 21).......  Randomized double-      Hypercholsterolemic     30 g/d test margarine  Controlled feeding     Total-C (mg/dL)
                                      blind, placebo-         adults, 32 enrolled,    consumed with 3        regimen; a prudent     Baseline:
                                      controlled, parallel    32 completed            meals                  fixed North American  C 263
                                      trial with 2 groups;   Age 25-60 y...........  C = margarine w/o       diet formulated to    I 260
                                      No run-in period; 30-  n = 16 (C)............   added PS.              meet Canadian         LDL-C % change
                                      d test period; 20-d    n = 16 (I)............  I = 1.7 g PS/d          recommended nutrient   compared to control:
                                      follow-up after test   Inclusion criteria:      sistostanol-           intakes                I [darr] 15.5% (p <
                                      period                  Total-C 252-387 mg/dL.  containing                                    0.05)
                                                             Canada................   phytosterols (20%
                                                                                sitostanol,
                                                                                remaining plant
                                                                                sterols are
                                                                                sitosterol,
                                                                                campesterol) as
                                                                                nonesterified tall
                                                                                oil.
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Nguyen et al., 1999 (Ref. 106).....  Multicenter             Mildly                  24 g/d U.S. vegetable  Usual dietary habits   Total-C % change
                                      randomized, double-     hypercholesterolemic    oil spread (three 8    maintained             compared to control:
                                      blind, placebo-         adults                  g servings/d)                                I1 [darr] 6.4*
                                      controlled parallel    Age  sd...  C = U.S. vegetable                            I2 [darr] 4.1*
                                      trial; 4-wk run-in     51.3  12.0   oil spread w/out                             *p < 0.001
                                      period, 8-wk test       to 54.5     added PS.                                    LDL-C % change
                                      period                  11.3 y.                I1 = 3 g PS/d as                               compared to control:
                                                             n = 76 (C)............   stanol esters in                             I1 [darr] 10.1*
                                                             n = 71 (I1)...........   U.S. vegetable oil                           I2 [darr] 4.1*
                                                             n = 77 (I2)...........   spread.                                      *p < 0.02
                                                             Inclusion criteria: 20  I2 = 2 g PS/d as
                                                              y, Total-C 200 and      stanol esters in
                                                              280 mg/dL.              U.S. vegetable oil
                                                             USA...................   spread.
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Sierksma et al., 1999 (Ref. 29)....  Balanced, double-blind  Healthy adults, 78      25 g/d Flora spread,   Habitual diets.        Total-C (mg/dL)
                                      crossover trial; 1-wk   enrolled, 76            with meals             Phytosterol-           Baseline:
                                      run-in, 3-wk test       completed              C = Flora spread w/o    containing spread     310 mg/dL
                                      period                 Age 18-62 y...........   added PS.              replaced all or part  Total-C (mg/dL)
                                                             n = 75................  I1 = 0.8 g PS/d as      of habitual spread    C 196
                                                             Inclusion criteria: <    nonesterified          or butter used for    I1 188*
                                                              Total-C < 309 mg/dL.    sterols in PS-         spreading             I2 194
                                                             The Netherlands.......   enriched Flora                               LDL-C (mg/dL)
                                                                                spread.                                      C 122
                                                                                I2 = 3.3 g PS/d as                            I1 114*
                                                                                esterified sterols                           I2 119
                                                                                in PS-enriched Flora                         Total-C % change
                                                                                spread.                                       compared to control:
                                                                                I1 [darr] 3.8%*
                                                                                LDL-C % change
                                                                                compared to control:
                                                                                I1 [darr] 6.0%*
                                                                                *p < 0.05
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Westrate and Meijer, 1998 (Ref. 31)  Balanced, Randomized    Normocholesterolemic    30 g/d margarine       Test margarine         Total-C (mg/dL)
                                      double-blind            and mildly              consumed at lunch      replaced margarines    Baseline:
                                      crossover trial; 5-d    hypercholesterolemic    and dinner             habitually used       207
                                      run-in, four test       adults, 100 enrolled,  C = Flora spread w/o                          Total-C % change
                                      periods of 3.5 wks      95 completed            added PS.                                     compared to control:
                                                             Mean age    I1 = 2.7 g PS/d as                            I1 [darr] 7.3%*
                                                              sd.                     plant stanol esters                          I2 [darr] 8.3%*
                                                             45  12.8 y   (2.7 g/d.                                    I3 [darr] 1.1%
                                                             n = 95................  I2 = 3.0 g PS/d as                            I4 [darr] 0.7%
                                                             Inclusion criteria:      soybean sterol                               LDL-C % change
                                                              Total-C < 310 mg/dL.    esters.                                       compared to control:
                                                             The Netherlands.......  I3 = 1.6 g PS/d as                            I1 [darr] 13%*
                                                                                rice bran                                    I2 [darr] 13%*
                                                                                nonesterified                                I3 [darr] 1.5%
                                                                                sterols.                                     I4 [darr] 0.9%