Double-Blind, Placebo-Controlled Study of Effects of Plant Sterol Enriched Vegetable Juice on Serum Cholesterol Concentrations in Mildly Hypercholesterolemic Subjects and Safety Evaluation

Abstract

A double-blind, placebo-controlled study was carried out to determine the effective dosage of a vegetable and fruit juice mix, enriched with free plant sterol (sterol VFJ), on serum concentrations of cholesterol and safety assessment was made for normocholesterolemic and mildly hypercholesterolemic Japanese subjects as high dosage (HG: 1.6 g sterol/day), low dosage (LG: 0.8 g sterol/day) and placebo control groups (CG). All subjects were continuously monitored during a 12-week treatment period and serum cholesterol were measured. Throughout the experiment, the subjects were allowed to engage in normal daily activities. It is noteworthy that total cholesterol (T-C) and LDL-cholesterol (LDL-C) in LG and HG decreased significantly at 4, 8 and 12 weeks (LG: p<0.05; HG: p<0.01) compared to the baseline (0 weeks). The degree of change in T-C (ΔT-C) and LDL-C (ΔLDL-C) in HG and LG compared to CG was significant at 4, 8 and 12 weeks (LG: p<0.05; HG: p<0.01). Stratified analysis indicated T-C and LDL-C in LG and HG of high T-C (T-C ≧ 220 mg/dL) subjects (CG: n=32; LG: n=31; HG: n=36) decreased significantly at 4, 8 and 12 weeks compared to the baseline (LG: p < 0.01; HG: p < 0.05). ΔT-C and ΔLDL-C in HG and LG compared CG significantly decreased at 8 and 12 weeks (LG: p<0.05; HG: p<0.05). But in normal T-C (T-C< 220 mg/dL) subjects (CG: n=19; LG: n=19; HG: n=18), T-C and LDL-C were significantly changed at some point during the period of treatment though not at 12 weeks. Sterol VFJ is thus shown less effective for diminishing serum lipid in normal and healthy subjects. Safety assessment data indicated significant change in some parameters, but which in all cases was within the normal range. No time-dependent or dosage-dependent change could be detected. From the present findings, sterol VFJ would appear a safe and effective beverage for improving serum lipid concentrations in normocholesterolemic and mildly hypercholesterolemic subjects. © 2006, Japan Oil Chemists' Society. All rights reserved.