Abstract
[Objectives] In a randomized placebo-controlled double-blind trial, we investigated the safety of long-term intake of chocolate containing plant sterol (1,200 mg/day) and its effect on serum cholesterol in subjects with borderline-high cholesterol or mild hypercholesterolemia. [Methods] Ninety-nine subjects (53 males and 46 females) were randomly assigned to two treatment groups: a placebo group given placebo chocolate, and a test group given chocolate containing plant sterol at 1,200 mg/day for 12 weeks. Every 4 weeks, fasting blood and urine samples were taken and several serum and urinary parameters were measured, including serum lipids. Adverse physical effects as well as signs and symptoms were also examined. [Results] In the test group, serum total cholesterol and LDL-cholesterol levels were significantly reduced at 4, 8, and 12 weeks after the start of taking chocolate containing plant sterol. In comparison with the placebo group, the test group showed significantly lower serum total cholesterol and LDL-cholesterol levels at 4 and 8 weeks. Results of laboratory examinations for adverse effects were all within the normal ranges. No adverse physical effects were found, nor were any signs or symptoms of adverse events observed during the experimental period in the test group. [Conclusions] Long-term intake of chocolate containing plant sterol reduces the serum total and LDL-cholesterol levels, and raises no safety concerns in subjects with borderline-high cholesterol or mild hypercholesterolemia.
