Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study
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To determine the effect of 4 weeks of supplementation, then, withdrawal of a dietary supplement (DS) containing red yeast rice extract, policosanol and artichoke leaf extract at twice the recommended daily dose (6 tablets, 6-TAB) compared to the usual dose (3-TAB) or to a placebo (PLA), on blood lipid profiles and safety biomarkers.
Forty-five healthy subjects (15 per group), with untreated hypercholesterolaemia, were included in this randomised, double-blind, placebo-controlled clinical trial.
After 4 weeks of supplementation, LDL-C was significantly lower in 6-TAB (−0.21 g/l; 95 % CI −0.38 to −0.03 g/l; p = 0.0217) and 3-TAB (−0.25 g/l; 95 % CI −0.42 to −0.07 g/l; p = 0.0071) compared to PLA, although no difference in LDL-cholesterol was observed between the two groups, while no effect was seen on triacylglycerol and HDL-cholesterol. Four weeks after the end of supplementation, no difference in LDL-C was seen between the PLA group and the DS-treated groups. The muscle breakdown biomarkers, as well as biomarkers of liver and renal function, were altered by neither dose of the DS. Acute application of the DS on permeabilised skeletal muscle fibres of rats did not induce deleterious effects on mitochondrial function.
Supplementation with twice the recommended dose of the DS was effective in reducing LDL-cholesterol and appeared safe, but according to the present results, no additional benefit could be achieved compared to the recommended dose.
KeywordsRed yeast rice Policosanols Artichoke leaf extract Muscle breakdown Withdrawal
Artichoke leaf extract
Red yeast rice
Upper limit of normality
The Laboratoire Lescuyer, a company commercialising the tested dietary supplement, financed this work. We would like to thank Wanda Lipski for language editing.
Conflict of interest
E.B., E.D., and S.L.P. are employees of the company Laboratoire Lescuyer. J.F.L. is the general director of the company. P.C., C.M., B.H. and M.C. are employed by Biofortis-Mérieux Nutrisciences. The companies Biofortis-Mérieux Nutrisciences and Laboratoire Lescuyer have carried out this trial as a joint venture. Y.Z. and J.M.B. have signed a consultancy agreement with Biofortis-Mérieux Nutrisciences. P.S. declares no conflict of interest.
- 2.Smith SC Jr, Benjamin EJ, Bonow RO et al (2011) AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation 124(22):2458–2473CrossRefGoogle Scholar
- 6.Klimek M, Wang S, Ogunkanmi A (2009) Safety and efficacy of red yeast rice (Monascus purpureus) as an alternative therapy for hyperlipidemia. Pharm Ther 34(6):313–327Google Scholar
- 7.Wider B, Pittler MH, Thompson-Coon J et al (2009) Artichoke leaf extract for treating hypercholesterolaemia. Cochrane Database Syst Rev (4):CD003335Google Scholar
- 10.Ogier N, Amiot MJ, George S et al (2012) LDL-cholesterol-lowering effect of a dietary supplement with plant extracts in subjects with moderate hypercholesterolemia. Eur J Nutr [Epub ahead of print]Google Scholar
- 12.Friedewald WT, Levy RI, Fredrickson DS (1972) Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 18(6):499–502Google Scholar
- 15.Jiang FY, Sun LP, Yang J (2011) Effects of xuezhikang at different doses on patients suffering from acute coronary syndrome after percutaneous coronary intervention. Zhongguo Zhong Xi Yi Jie He Za Zhi 31(12):1607–1610 (In Chinese)Google Scholar
- 16.Pons P, Rodriguez M, Robaina C et al (1994) Effects of successive dose increases of policosanol on the lipid profile of patients with type II hypercholesterolaemia and tolerability to treatment. Int J Clin Pharmacol Res 14(1):27–33Google Scholar
- 21.Heber D, Yip I, Ashley JM et al (1999) Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Am J Clin Nutr 69(2):231–236Google Scholar
- 22.Englisch W, Beckers C, Unkauf M et al (2000) Efficacy of artichoke dry extract in patients with hyperlipoproteinemia. Arzneimittelforschung 50(3):260–265Google Scholar
- 23.Castano G, Fernandez L, Mas R et al (2002) Comparison of the efficacy, safety and tolerability of original policosanol versus other mixtures of higher aliphatic primary alcohols in patients with type II hypercholesterolemia. Int J Clin Pharmacol Res 22(2):55–66Google Scholar
- 25.Tomaszewski M, Stepien KM, Tomaszewska J et al (2011) Statin-induced myopathies. Pharmacol Rep 63(4):859–866Google Scholar