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

NCT ID: NCT01139398

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-01-31

Brief Summary

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

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).

Conditions

Delivery of Health Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

Limicol (plant extract)

Artichoke extract, anti-caking agents: dicalcium phosphate, calcium citrate, vegetable magnesium stearate, red yeast rice, microcrystalline cellulose, natural vitamin E, garlic extract, sugar cane policosanols, inositol hexanicotinate, vitamin B3, vitamin B2.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Limicol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

Lescuyer Laboratory

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biofortis

Nantes, , France

Countries

France

Other Identifiers

L2009-06

Identifier Type: -

Identifier Source: org_study_id