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

Delivery of Health Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139398
• Other study ID #: L2009-06
• 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

• Delivery of Health Care
• Hypercholesterolemia

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