Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Primary Purpose
Delivery of Health Care
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Limicol (plant extract)
Sponsored by
About this trial
This is an interventional treatment trial for Delivery of Health Care focused on measuring Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess.
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.
Sites / Locations
- Biofortis
Outcomes
Primary Outcome Measures
LDL-cholesterol levels
Secondary Outcome Measures
Total cholesterol, HDL-cholesterol, triglycerides levels
Full Information
NCT ID
NCT01139398
First Posted
June 7, 2010
Last Updated
February 21, 2012
Sponsor
Lescuyer Laboratory
Collaborators
BioFortis
1. Study Identification
Unique Protocol Identification Number
NCT01139398
Brief Title
Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Official Title
Effect of Dietary Supplement Limicol on LDL-cholesterol Levels in Moderate Hypercholesterolaemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lescuyer Laboratory
Collaborators
BioFortis
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delivery of Health Care
Keywords
Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Limicol (plant extract)
Other Intervention Name(s)
Limicol
Intervention Description
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.
Primary Outcome Measure Information:
Title
LDL-cholesterol levels
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Total cholesterol, HDL-cholesterol, triglycerides levels
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Biofortis
City
Nantes
ZIP/Postal Code
44200
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
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