Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
The purpose of this study is to validate the effectiveness of food supplement Limicol on reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Dietary Supplement Limicol on LDL-cholesterol Levels in Moderate Hypercholesterolaemia|
- LDL-cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Total cholesterol, HDL-cholesterol, triglycerides levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Dietary Supplement: Limicol (plant extract)
Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the leading cause of mortality and morbidity in France. These diseases are multifactorial origin and even if it is not possible to act on risk markers such as age, sex, or heredity, risk factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical inactivity, are the main target of prevention strategies.The dydlipidémies have a role in the formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and are greeted by macrophages. Following a succession of different processes including inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and inflammation are interesting strategies in the context of cardiovascular prevention. Several scientific study showed that nutritional supplementation with some plant extracts such as artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several cardiovascular risk factors including regulate concentrations of circulating lipids.
The objective of this study is to validate the effectiveness of Limicol, formulated with proven scientific data on the reduction of LDL-cholesterol in volunteers with moderate hypercholesterolaemia (LDL-cholesterol).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139398
|Nantes, France, 44200|