Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Keywords
Abstract
Description
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).
Dates
| Last Verified: | 01/31/2012 |
| First Submitted: | 06/06/2010 |
| Estimated Enrollment Submitted: | 06/06/2010 |
| First Posted: | 06/07/2010 |
| Last Update Submitted: | 02/20/2012 |
| Last Update Posted: | 02/21/2012 |
| Actual Study Start Date: | 04/30/2010 |
| Estimated Primary Completion Date: | 10/31/2011 |
| Estimated Study Completion Date: | 12/31/2011 |
Condition or disease
Intervention/treatment
Dietary Supplement: Limicol (plant extract)
Phase
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - About 18 to 65 years (inclusive). - Subject has a stable weight for at least three months before the start of the study. - Subject able and willing to comply with the protocol and agreeing to give their consent in writing. - Subject affiliated with a social security scheme. - Subject willing to be included in the national register of volunteers who lend themselves to biomedical research. |
Outcome
Primary Outcome Measures
1. LDL-cholesterol levels [4 months]
Secondary Outcome Measures
1. Total cholesterol, HDL-cholesterol, triglycerides levels [4 months]
