Six weeks of supplementation with the Nature Made (Pharmavite) branded CholestOff supplement reduced LDL cholesterol levels by 4.9% and total cholesterol by 2.8% when the supplement was used in combination with the National Cholesterol Education Program (NCEP) therapeutic lifestyle changes (TLC) diet.
Scientists from Provident Clinical Research/Biofortis North America and Pharmavite report their findings in the International Journal of Food Sciences and Nutrition.
“The results of this study are both statistically significant and clinically relevant,” said Provident’s Kevin Maki, PhD, and co-author of the study.
“The study demonstrates that this supplement containing free (non-esterfied) phytosterols, when added to the NCEP’s TLC diet, significantly reduced the levels of both total and LDL (bad) cholesterol among the study participants, all of whom had elevated cholesterol initially.”
The study was sponsored by Pharmavite LLC.
Sterols/stanols and cholesterol
Numerous clinical trials in controlled settings have reported that daily consumption of 1.5 to 3 grams of phytosterols/-stanols from foods can reduce total cholesterol levels by 8 to 17%, representing a significant reduction in the risk of cardiovascular disease.
The majority of these clinical trials examining the effects of phytosterols on cholesterol have used food forms including margarine-type spreads, orange juice, yogurt and yogurt-based drinks.
However, few have investigated the effects of phytosterols as supplements, said Dr Maki and his co-workers.
To redress this balance, the researchers recruited 32 men and women, aged between 21 and 79 with elevated LDL cholesterol levels. Participants were randomly assigned to receive 1.8 grams daily of free plant sterols and stanols (Cholestoff, Pharmavite) or placebo for six weeks in combination with the TLC diet.
Results of the double-blind crossover study indicated that the sterol group displayed an average 4.9% decrease in LDL levels, an average 3.6% decrease in non-HDL levels, and a 2.8% decrease in total cholesterol levels, compared to the control.
On the other hand, no changes were observed for HDL or triglyceride levels, added the researchers.
“Intervention trials have shown that each 1% reduction in LDL-C (or non-HDL-C) lowers the risk of a major cardiovascular event by about 1% over a period of 5 years,” explained the researchers. “However, the cardiovascular benefit of maintaining low levels of atherogenic lipoprotein cholesterol levels over decades may be larger than would be predicted on the basis of results from short-term cholesterol-lowering intervention trials.
“Each 1% reduction in LDL-C or non-HDL-C may be associated with as much as a 3% reduction in [coronary heart disease] event risk if maintained over an extended period.”
Pharmavite’s director of scientific affairs & nutrition education Belinda Jenks, PhD, said the study adds to the body of knowledge that supports the use of this dietary supplement of phytosterols in the appropriate daily dosages as an effective approach to lower LDL cholesterol in conjunction with a healthy diet and exercise program.
Dr Jenks, who was a co-author of the study, added that the supplement “can easily be added to a cholesterol-lowering regimen without negatively impacting a person’s diet or caloric intake”.
Source: International Journal of Food Sciences and Nutrition
Published online ahead of print, doi: 10.3109/09637486.2011.636345
“Lipid-altering effects of a dietary supplement tablet containing free plant sterols and stanols in men and women with primary hypercholesterolaemia: a randomized, placebo-controlled crossover trial”
Authors: K.C. Maki, A.L. Lawless, M.S. Reeves, M.R. Dicklin, B.H. Jenks, E. Shneyvas, J.R. Brooks