Dose Effect of Limicol on (LDL)-Cholesterol Levels

Study Overview
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Brief Summary
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The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.

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

Conditions
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Hypercholesterolaemia

Intervention / Treatment
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* Dietary Supplement: Limicol
* Dietary Supplement: Limicol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Limicol simple dose<br> | Dietary Supplement: Limicol<br>* 3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment<br>|
| Experimental: Limicol double doses<br> | Dietary Supplement: Limicol<br>* 6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group) |  | 4 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group) |  | 4 weeks after baseline | 
| Change from Baseline in blood total cholesterol, HDL-cholesterol and TAG levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group versus placebo group) |  | 4 weeks after baseline | 
| Change from Baseline in blood LDL-cholesterol, total cholesterol, HDL-cholesterol and TAG levels 4 weeks after end of supplementation (limicol double dose group versus limicol simple dose group versus placebo group) |  | 8 weeks after baseline | 
| Change from Baseline in CK, LDH and other safety biomarkers levels after 4 weeks of supplementation (limicol double dose group versus placebo group versus placebo group) |  | 4 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess, Delivery of Health Care