Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia

Sponsor

Lescuyer Laboratory (Industry)

Overall Status

Completed

CT.gov ID

NCT01139398

Collaborator

BioFortis (Other)

100

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to validate the effectiveness of food supplement Limicol on reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.

Condition or Disease	Intervention/Treatment	Phase
Delivery of Health Care	Dietary Supplement: Limicol (plant extract)	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Dietary Supplement Limicol on LDL-cholesterol Levels in Moderate Hypercholesterolaemia

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Outcome Measures

Primary Outcome Measures

LDL-cholesterol levels [4 months]

Secondary Outcome Measures

Total cholesterol, HDL-cholesterol, triglycerides levels [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.