Table 1.
Selected clinical studies reporting changes in plasma triglyceride concentrations in response to phytosterol/phytostanol supplementation.
| Study | n | Duration | Design | Dose | Vehicle | Baseline TG (mmol/L) |
Effect on TG Level (% change from baseline) |
|
|---|---|---|---|---|---|---|---|---|
| Maki et al. [7] | 28 7M 21F |
Primary hypercholesterolaemia | 6 wks | Randomized, single-blinded, placebo-controlled, crossover NCEP TLC weight maintenance diet |
1.8 g/d(81% PS & 19% PSA) | Capsule | 1.41 | vs. Base: ↓4% vs. Ctl:↓ 9.1% |
| Sialvera et al. [9] | 101 60M 48F |
Metabolic syndrome | 2 mo | Randomized, single-blinded, placebo-controlled, parallel-arm Western-type diet |
4 g/d PS | Yogurt beverage | 2.20 | vs. Base: ↓24% vs. Ctl: ↓12.5% |
| Sanchez-Muniz et al. [8] | 217 | Hypercholesterolaemic, stratified by carrier of the Apo E2 (E2E2), E3 (E3E3) and E4 (E3E4, E4E4) alleles | 5 wks | Randomized, double-blinded, placebo-controlled parallel-arm NCEP Step 1 diet |
1.1–2.2 g/d PS | Margarine | E2: 1.66 E3: 1.33 E4: 1.69 |
E2 vs. Ctl: ↓15.5% E3 vs. Ctl: ns E4 vs. Ctl: ns |
| Theuwissen et al. [10] | 28 16M 12F |
Elevated triglyceride levels | 3 wks | Randomized, double-blinded, placebo-controlled parallel-arm Habitual diet |
2.5 g/d PSA | Margarine | 2.63 | vs. Base: ↓11% (subjects with baseline TG > 2.3 mmol/L) |
| Plat et al. [11] | 18 | Dyslipidemic metabolic syndrome | 8 wks | Randomized, double-blinded, Placebo-controlled, parallel-arm | 2.0 g/d PSA | Yogurt beverage | 2.21 | vs. Base: ↓28% |
| 75 | Normolipidemic | 8 wks | Randomized, double-blinded, Placebo-controlled, parallel-arm | 3.8–4.1 g/d PSA | Margarine and shortenings | 1.02 | ns | |
| Rideout et al. [12] | 33 15M 18F |
Normolipidemic | 28 d | Randomized, placebo-controlled, crossover Controlled feeding trial (50% CHO, 35% fat, 15% protein) |
1.95 g/d PS | Low fat soy beverage | 1.65 | ns |
| 23 10M 13F |
Hypercholesterolaemic | 28 d | Randomized, placebo-controlled, crossover Controlled feeding trial (50% CHO, 35% fat, 15% protein) |
1.95 g/d PS | Moderate fat soy beverage | 2.06 | vs. Ctl: ↓9.4% | |
| Plat et al. [13] | 36 23M 13F |
Metabolic syndrome | 8 wks | Randomized, placebo-controlled parallel-arm | 2.0 g/d PSA | Yogurt beverage | 2.21 | vs. Base: ↓15.9% vs. Ctl: ↓44.5% |
| Clifton et al. [14] | 151 77M 74F |
Hypercholesterolemic | 6 wks | Randomized, double-blinded, placebo-controlled parallel-arm Habitual diet |
Wk 0–3: 1.6 g/d PS Wk 3–6: 3.0 g/d PS |
Margarine | 1.92 |
Wk 0–3 vs. Base: ↓12.5% vs. Ctl: ↓17.4% Wk: 3–6 vs. Base: ↓12.5% vs. Ctl: ↓21.5% |
| Plana et al. [15] | 83 | Hypercholesterolaemic | 6 wks | Multi-centre, randomized, double-blind, placebo-controlled, parallel-arm | 1.6 g/d PS | Yogurt beverage | 1.55 | vs. Base: ↓7% vs. Ctl: ↓14% |
| Judd et al. [16] | 53 26M 27F |
Normocholesterolaemic and mildly hypercholesterolaemic | 3 wks | Randomized, placebo-controlled, double-blind, crossover | 3.6 g/d PS | Salad dressing | 1.46 | vs. Ctl: ↓7.3% |
| Davidson et al. [17] | 84 46M 38F |
Healthy | 8 wks | Randomized, double-blind, placebo-controlled, parallel-arm Habitual diet |
3.0 g/d PS 6.0 g/d PS 9.0 g/d PS |
Reduced fat spread and/or salad dressing | 1.20 1.18 1.47 |
3.0 g/d, vs. Base: ↓13.3% 6.0 g/d, vs. Base: ns 9.0 g/d, vs. Base: ns |
| Jones et al. [18] | 15M | Hypercholesterolaemic | 21 d | Randomized, double-blind, placebo-controlled, crossover Controlled feeding trial (50% CHO, 35% fat, 15% protein) |
1.84 g/d PS 1.84 g/d PSA |
Margarine | 2.52 2.39 |
PS vs. Base: ↓18.9% vs. Ctl: ↓1.0% PSA vs. Base: ↓17.4% vs. Ctl: ↓0.9% |
| Shaghaghi et al. [19] | 47 25M 22 F |
Mild to moderately hypercholesterolaemic | 29 d | Randomized, placebo-controlled, crossover Habitual diet |
2.0 g/d water dispersible PS | Yogurt | 1.68 | vs. Base: ↓0.8% vs. Ctl: ↓13.9% |