Comparison of the Efficacy of Plant Sterol-Enriched Soymilk Versus Plain Soymilk in Volunteers With High LDL-Cholesterol

NACompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

November 30, 2013

Study Completion Date

April 30, 2014

Conditions
Hypercholesterolemia
Interventions
DIETARY_SUPPLEMENT

plant sterol and soluble fiber-enriched soymilk

Sterols compete with LDL-C for absorption in GI tract. A meta-analysis of 41 trials indicated that an intake of 2 g sterols/stanols reduces the LDL-C level by 10%. Additive effects occur when sterols are combined with statins; the combination being more efficacious than a 2 times up-dosing of statins alone. Soluble dietary fibers also have significant cholesterol lowering effects. In a meta-analysis, Brown et al estimate that a daily soluble fiber intake ranging from 9-30 g/d, were associated with 10.6% reduction in LDL-C levels.

DIETARY_SUPPLEMENT

soymilk

Soy protein is another LDL-C and total cholesterol lowering food. A meta-analysis by Reynolds K et al. discovered that volunteers receiving 20 to more than 61 g of soy protein had reductions in total cholesterol by 5.26 mg/dL (95% CI -7.14 to -3.38), and LDL-C by 4.25 mg/dL (95% CI -6.00 to -2.50), with an increase of HDL-C by 0.77 mg/dL (95% CI 0.20 to 1.34). Reductions in LDL cholesterol were larger in hypercholesterolemic than in normocholesterolemic subjects.

Trial Locations (1)

50200

Clinical trial Unit, Faculty of Medicine, Chiang Mai University, Muang

All Listed Sponsors
lead

Chiang Mai University

OTHER

NCT02459314 - Comparison of the Efficacy of Plant Sterol-Enriched Soymilk Versus Plain Soymilk in Volunteers With High LDL-Cholesterol | Biotech Hunter | Biotech Hunter