Effect of sugar cane policosanol on lipid profile in primary hypercholesterolemia

Abstract

Policosanol, a mixture of long-chain aliphatic primary alcohols, is used as a cholesterol-lowering supplement. The effectiveness of policosanol is still questionable. To determine the lipoprotein-lowering effects of Cuban sugar cane-derived policosanol a double-blind, randomized, placebo controlled trial was performed. Sixty-eight primary hypercholesterolemic subjects were enrolled and randomly assigned to the treatment or to the control group. The first group received sugar cane policosanol 20 mg daily for 8 weeks, while the control group was treated with placebo. All subjects followed a normocaloric diet. The content of policosanol in the supplement tablets was assessed by gas chromatography. A total of 32 subjects in the policosanol group and 31 subjects in the control group completed the study. Body mass index, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglyceride plasma levels did not change significantly in either group. In conclusion, sugar cane policosanol at doses of 20 mg daily showed no lipid lowering effects in subjects with primary hypercholesterolemia.

The oleic acid esterification of policosanol increases its bioavailability and hypocholesterolemic action in rats

“…The data presented for the NEP group are consistent with recent studies showing the lack of policosanol effect in modifying total or LDLcholesterol (Greyling et al, 2006;Berthold et al, 2006;Dulin et al, 2006;Kassis and Jones, 2006;Francini-Pesenti et al, 2008a;Francini-Pesenti et al, 2008b;Kassis et al, 2007;Murphy et al, 2008), considering that the supplementation of rats with 100 mg/kg body weight of NEP, the same form of administration in previously reported investigations, did not alter lipid concentrations when compared to the control group. Nevertheless, the OAEP group exhibited significantly lower concentrations of plasmatic LDL-cholesterol, as the primary endpoint, and total cholesterol, as the secondary endpoint, in normocholesterolemic rats after 5 weeks of treatment.…”

“…However, recent clinical trials failed to show significant effects. In fact, no changes in lipid variables in subjects receiving policosanol were reported (Greyling et al, 2006;Berthold et al, 2006;Dulin et al, 2006;Kassis and Jones, 2006) and neither primary hypercholesterolemic subjects (Francini-Pesenti et al, 2008a) nor diet-resistant hypercholesterolemic patients (Francini-Pesenti et al, 2008b) were affected by policosanol treatment for 8 weeks.…”

Scientific Opinion on the substantiation of health claims related to policosanols from sugar cane wax and maintenance of normal blood LDL-cholesterol concentrations (ID 1747, 1748, 1864, 1951, 1954, 4693) and maintenance of normal blood HDL-cholesterol co

“…All of these studies except four (Berthold et al, 2006;Francini-Pesenti et al, 2008a;2008b;Kassis andJones, 2006, 2008) were conducted in Cuba in Cuban subjects by a single research team using policosanols from Cuban sugar cane wax produced by a single company. In these placebo-controlled, double-blind, randomised controlled trials, the efficacy of policosanols on blood lipids was studied in groups of hypercholesterolaemic subjects (non-insulin dependent diabetics, post-menopausal women, elderly, subjects at high risk of coronary heart disease) (Batista et al, 1996;Canetti et al, 1997;Castaño et al, 1995;Castaño et al, 1999;2001;Crespo et al, 1999;Pons et al, 1994), and in one group of healthy subjects (Hernández et al, 1992).…”

“…In a double-blind, randomised, placebo-controlled study, 68 subjects with LDL-cholesterol concentrations between 160 and 250 mg/dL followed a normocaloric diet according to the National Cholesterol Education Program Adult Treatment Panel III for three months, and thereafter were randomised to consume either two tablets of policosanols (each tablet containing 10 mg policosanols from Cuban sugar cane wax) or placebo (calcium phosphate, calcium carbonate and magnesium stearate) after dinner for eight weeks, while following their usual lifestyle and a normocaloric diet (Francini-Pesenti et al, 2008a). It was estimated that to achieve 80 % power to detect a reduction in serum LDL-cholesterol concentrations of 20 % at a 2-sided significance level of 5 %, 30 subjects per group would be required.…”

“…Power calculations were performed as described in the study by Francini-Pesenti et al (2008a In a double-blind, placebo-controlled, cross-over study by Kassis andJones (2006, 2008) 22 subjects with LDL-cholesterol concentrations between 3.0 and 5.0 mmol/L were recruited to receive either 10 g margarine containing 10 mg policosanols derived from sugar cane wax or a placebo margarine for 28 days each, with a 28-day wash-out period in between. A sample size of 21 was calculated to provide an 80 % probability of detecting a difference of 20 % between groups in the parameters measured, using a coefficient of variation of 15-20 %.…”