Effect of Cholactiv™ supplementation in subjects with moderate cardiovascular risk

Background. Altered lipid levels and lipoprotein oxidation greatly contribute to atherogenesis and cardiovascular risk. CholactivTM is a natural supplement containing lycopene, policosanols from rice, polyphenols under the form of Leucoselect-R Phytosome-R and evening primrose oil. Although there are several studies that evaluated the ability of the individual components of CholactivTM to reduce blood lipid levels, there are no reports on the effect of their combination. Aim. The aim of this study was therefore to explore the feasibility and test the efficacy of its administration to human volunteers in order to evaluate whether CholactivTM supplementation improves lipid profile and reduces cardiovascular risk in subjects at moderate global risk of cardiovascular disease. The latter, indeed, do not have presently any indication for treatment with statins. Methods. The study was designed as a placebo-controlled, randomized, double-blind trial with 2 parallel arms, CholactivTM and placebo. After screening 335 volunteers, 224 male and female volunteers, aged 35 to 69 years, with a global cardiovascular risk between 5 and 19 % were included into the study. Finally, a total of 188 subjects successfully concluded the study: 91 under CholactivTM and 97 under Placebo. After a run-in phase of 1 week, participants were randomized to receive dietary advice plus either CholactivTM or placebo for 6 months in a double-blind manner. One capsule of CholactivTM or placebo, was taken twice daily, unchewed, during the main meals. The intervention lasted 24 weeks (6 months). Clinical visit, blood drawing, urine collection and clinical tests were performed, after an overnight fasting, at screening visit -1, 0, 1 and 2 (before and after a post-prandial oxidative stress) (day -7, 0, 3 and 6 months after supplementation, respectively). A 3-day food diary was filled by each participant before visit 0, 1 and 2. After recruitment selection, at visit 0, 1 and 2, each participant was subjected to blood drawing and urine collection for biochemical analyses, measurement of systolic and diastolic blood pressure, pulse rate, height and weight for BMI calculation and waist and hip circumferences, evaluation of endothelial function, administration of questionnaires for cardiovascular risk factors and dietary habits and calculation of global cardiovascular risk. Results and conclusions. CholactivTM was effective in reducing both total and LDL cholesterol. The effect was time-dependent, being already present after three months of treatment and further increasing after 6 months. CholactivTM also significantly reduced triglyceride levels after 6 month treatment. The final change was around -8% for cholesterol, -5% for LDL and -18% for triglycerides: the net change on triglyceride and LDL was comparable with that reported after omega 3 supplementation (1). CholactivTM however also decreased total cholesterol levels, while omega 3 fatty acids did not. Although not significant, there was a trend towards a decrease of the global cardiovascular risk, that could have been possibly more evident with a longer treatment period. A significant decrease over time was observed in body weight, BMI and waist circumference both in placebo and CholactivTM group. Hip circumference decreased only in the CholactivTM group. The administration of CholactivTM for 6 months was safe, well tolerated and did not induce any relevant side effect. It is reasonable therefore to suggest that CholactivTM, in addition to dietary advice, might produce clinically relevant benefits in the primary prevention of cardiovascular disease.