- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01139398
Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Effect of Dietary Supplement Limicol on LDL-cholesterol Levels in Moderate Hypercholesterolaemia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nantes, France, 44200
- Biofortis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
LDL-cholesterol levels
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total cholesterol, HDL-cholesterol, triglycerides levels
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- L2009-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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