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| Name | Class |
|---|---|
| BioFortis | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Limicol simple dose | Experimental |
| |
| Limicol double doses | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limicol | Dietary Supplement | 3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment |
|
| 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 |
| 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) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastien Peltier, PhD | Lescuyer Laboratory | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Nantes | 44000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23266743 | Derived | Barrat E, Zair Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M, Peltier SL. Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study. Eur J Nutr. 2013 Dec;52(8):1843-52. doi: 10.1007/s00394-012-0486-2. Epub 2012 Dec 25. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Limicol | Dietary Supplement | 6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment |
|
| Placebo | Other | 6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment |
|
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |