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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01139398
Other study ID # L2009-06
Secondary ID
Status Completed
Phase N/A
First received June 7, 2010
Last updated February 21, 2012
Start date May 2010
Est. completion date January 2012

Study information

Verified date February 2012
Source Lescuyer Laboratory
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 2012
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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.

Locations

Country Name City State
France Biofortis Nantes

Sponsors (2)

Lead Sponsor Collaborator
Lescuyer Laboratory BioFortis

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary LDL-cholesterol levels 4 months No
Secondary Total cholesterol, HDL-cholesterol, triglycerides levels 4 months No
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