Six weeks of supplementation were associated with a 17% reduction in LDL cholesterol and a 14% reduction in total cholesterol, Indena scientists and researchers from the Grant Medical College Mumbai and the Drug Research Laboratory in Mumbai report in Phytotherapy Research.
In addition, the study’s findings also supported the safety profile of Indena’s CholActiv-branded ingredient, with no changes in the measures of any safety parameter noted during the intervention period.
“It is reasonable to conclude that a combined rational supplementation, as the case of CholActiv, is safe and effective in lowering the elevated total cholesterol and the LDL‐cholesterol levels in patients with mild hypercholesterolemia and mixed dyslipidemia,” wrote the researchers, led by Indena’s Antonella Riva.
High cholesterol levels, hypercholesterolemia, have a long association with many diseases, particularly cardiovascular disease (CVD), the cause of almost 50 per cent of deaths in Europe and the US.
A recent report from the American Heart Association predicted a tripling of direct medical costs of cardiovascular disease from $272.5 billion to $818.1 billion between 2010 and 2030 (Circulation, March 2011, Vol. 123, pp. 933-944).
Riva and her co-workers recruited 60 people with high cholesterol levels or abnormal blood lipid profiles and randomly assigned them to receive either the CholActiv supplement or placebo for six weeks. The subjects then had a two week ‘washout’ period with no intervention, and were then crossed over to the other group so that all 60 people participated in the active and placebo groups.
The patented CholActiv supplement was administered as soft‐gelatin capsules containing policosanol (at least 70% octacosanol), tomato extract (at least 10% lycopene), grape procyanidins, and Oenothera biennis oil (at least 9% cis‐gamma‐linolenic acid, GLA).
Results showed that the active supplement produced significant reductions in LDL and total cholesterol of 17.3% and 13.4%, respectively.
In addition, levels of C-reactive protein (CRP - a well established marker of inflammation), malondialdehyde (MDA - a reactive carbonyl compound and a well-established marker of oxidative stress), and superoxide dismutase (SOD – an antioxidant enzyme) decreased by 7.2%, 8.9% and 2.8%, respectively, after six weeks of supplementation. Levels of these compounds increased during the placebo period.
Despite the positive results, the researchers called for “further long term studies, conducted in a larger population of patients, […] to validate the role of CholActive in modifying the values of oxidative stress indexes”.
Source: Phytotherapy Research
Volume 26, Issue 2, pages 265–272, doi: 10.1002/ptr.3542
“A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Efficacy and Tolerability of an Optimized Botanical Combination in the Management of Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia”
Authors: H. Gupta, D. Pawar, A. Riva, E. Bombardelli, P. Morazzoni