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| Name | Class |
|---|---|
| Hopital Gabriel Montpied | OTHER |
| Centre de Recherche en Nutrition Humaine d'Auvergne | OTHER_GOV |
| Clinical Of Medical Cardio Pneumologie, Durtol | OTHER |
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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. Dydlipidemias 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.
In this study, we hypothesize that the food supplement LIMICOL contributes to reducing LDL cholesterol in the context of care for patients (dietary measures and physical activity)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIMICOL | Experimental | LIMICOL : red yeast rice (with monacolin K, 2 mg), artichoke leaf extract, policosanols, French maritime Pine bark extract, Garlic extract, vitamins E, B2 and B3. 1 tablet during the 3 principal meals for 12 weeks. |
|
| PLACEBO | Placebo Comparator | dicalcium phosphate, calcium citrate, vegetable magnesium stearate, microcrystalline cellulose, Maltodextrin, Tricalcium phosphate, Beet powder, Yellow coloring shellac, Brown coloring shellac. 1 tablet during the 3 principal meals for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIMICOL | Dietary Supplement | Suplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-cholesterol levels (g/l) at the end of study | Effect of LIMICOL supplementation showed by ANCOVA analysis of LDL cholesterol (g/l), with baseline LDL as covariable | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle function on tissue biopsy | Mitochondrial respiration of muscle histology. Expressed as pmol/s/ml. | Week 0; Week 12 |
| Total cholesterol | Total cholesterol. Expressed as g/l, variation (g/l and %) compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martine Duclos, Pr | CHU G. Montpied | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont Université, Université Blaise Pascal, EA 3533, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), BP 10448 | Clermont-Ferrand | F-63000 | France |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Université d'Auvergne |
| OTHER |
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| PLACEBO | Dietary Supplement | Suplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks. |
|
| Week 0; Week 6; Week 12 |
| HDL-cholesterol | HDL. Expressed as g/l, variation (g/l and %) compared to baseline. | Week 0; Week 6; Week 12 |
| Triglycerides | Triglycerides. Expressed as g/l, variation (g/l and %) compared to baseline. | Week 0; Week 6; Week 12 |
| LDLox | oxydized LDL. Expressed as pg/ml, variation (pg/l and %) compared to baseline. | Week 0; Week 6; Week 12 |
| CoQ10 | circulating coenzyme Q10. Expressed as pg/ml. variation (pg/l and %) compared to baseline. | Week 0; Week 12 |
| ApoA1 | Circulating ApoLipoprotein A1. Expressed as g/ml. variation (g/l and %) compared to baseline. | Week 0; Week 12 |
| ApoB | Circulating ApoLipoprotein B. Expressed as g/ml. variation (g/l and %) compared to baseline. | Week 0; Week 12 |
| Glycemia | Glycemia. Expressed as mmol/l. variation (mmol/l and %) compared to baseline. | Week 0; Week 12 |
| Insulinemia | Insulinemia. Expressed as mUI/l. variation (mUI/l and %) compared to baseline. | Week 0; Week 12 |
| Myoglobin | Myoglobin. Expressed as µgI/l. variation (µg/l and %) compared to baseline. | Week 0; Week 12 |
| CK | Creatin kinase. Expressed as UI/l. variation (UI/l and %) compared to baseline. | Week 0; Week 12 |
| LD | Lactate Dehydrogenase. Expressed as UI/l. variation (UI/l and %) compared to baseline. | Week 0; Week 12 |
| AST | Aspartate transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline. | Week 0; Week 12 |
| ALT | Alanine transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline. | Week 0; Week 12 |
| ALP | Alkaline phosphatase. Expressed as UI/l. variation (UI/l and %) compared to baseline. | Week 0; Week 12 |
| GGT | Gamma-glutamyltransferase. Expressed as UI/l. variation (UI/l and %) compared to baseline. | Week 0; Week 12 |
| Bilirubin | Bilirubin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline. | Week 0; Week 12 |
| Albumin | Albumin. Expressed as g/l. variation (g/l and %) compared to baseline. | Week 0; Week 12 |
| Total Protein | Total Protein. Expressed as g/l. variation (g/l and %) compared to baseline. | Week 0; Week 12 |
| usCRP | ultrasensible C-reactiv protein. Expressed as mg/l. variation (mg/l and %) compared to baseline. | Week 0; Week 12 |
| Creatinin | Creatinin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline. | Week 0; Week 12 |
| Urea | Urea. Expressed as µmol/l. variation (µmol/l and %) compared to baseline. | Week 0; Week 12 |
| VO2 MAX | VO2MAX. Expressed as ml/min/kg. variation (ml/min/kg and %) compared to baseline. | Week 0; Week 6; Week 12 |
| Max Strength | Max grip strength. Expressed as N. variation (N and %) compared to baseline. | Week 0; Week 6; Week 12 |
| Weight | Body Weight. Expressed as Kg. variation (Kg and %) compared to baseline. | Week 0; Week 6; Week 12 |
| Fat mass | Fat Mass measured by DEXA. Expressed as % body mass. variation (%) compared to baseline. | Week 0; Week 12 |
| CRNH-Auvergne | Clermont-Ferrand | F-63001 | France |
| Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied | Clermont-Ferrand | F-63003 | France |
| Clinique de cardiopneumologie de DURTOL | Durtol | F-63830 | France |
| D009750 |
| Nutritional and Metabolic Diseases |