Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.
- Conditions
- Hypercholesterolemia
- Interventions
- Dietary Supplement: LIMICOLDietary Supplement: PLACEBO
- Registration Number
- NCT05750602
- Lead Sponsor
- Lescuyer Laboratory
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- BMI between 25 and 35 kg/m²
- Subject has a stable weight for at least three months before the start of the study.
- LDL ≥ 1.50 g/L
- 0.9 g/L ≤ triglycerides ≤ 4.00 g/L
- Subject able and willing to comply with the protocol and agreeing to give his informed consent in writing;
- Subject affiliated with a social security scheme
- Subject having a confirmed or suspected food allergy, notably to one of the components of the study product;
- Subject suffering from a severe chronic condition deemed incompatible with participation in the study by the investigator
- Subject with glaucoma
- Subject with uretroprostatic disorder
- Subjet anxious (score >9 HAD scale)
- Subject with diabetes
- Subjet with treatment anticoagulant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LIMICOL LIMICOL 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 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.
- Primary Outcome Measures
Name Time Method LDL-cholesterol levels (g/l) at the end of study Week 12 Effect of LIMICOL supplementation showed by ANCOVA analysis of LDL cholesterol (g/l), with baseline LDL as covariable
- Secondary Outcome Measures
Name Time Method HDL-cholesterol Week 0; Week 6; Week 12 HDL. Expressed as g/l, variation (g/l and %) compared to baseline.
Glycemia Week 0; Week 12 Glycemia. Expressed as mmol/l. variation (mmol/l and %) compared to baseline.
Insulinemia Week 0; Week 12 Insulinemia. Expressed as mUI/l. variation (mUI/l and %) compared to baseline.
Albumin Week 0; Week 12 Albumin. Expressed as g/l. variation (g/l and %) compared to baseline.
ApoA1 Week 0; Week 12 Circulating ApoLipoprotein A1. Expressed as g/ml. variation (g/l and %) compared to baseline.
ALT Week 0; Week 12 Alanine transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
ALP Week 0; Week 12 Alkaline phosphatase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
GGT Week 0; Week 12 Gamma-glutamyltransferase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Total cholesterol Week 0; Week 6; Week 12 Total cholesterol. Expressed as g/l, variation (g/l and %) compared to baseline.
Triglycerides Week 0; Week 6; Week 12 Triglycerides. Expressed as g/l, variation (g/l and %) compared to baseline.
CoQ10 Week 0; Week 12 circulating coenzyme Q10. Expressed as pg/ml. variation (pg/l and %) compared to baseline.
Myoglobin Week 0; Week 12 Myoglobin. Expressed as µgI/l. variation (µg/l and %) compared to baseline.
LD Week 0; Week 12 Lactate Dehydrogenase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Urea Week 0; Week 12 Urea. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
Weight Week 0; Week 6; Week 12 Body Weight. Expressed as Kg. variation (Kg and %) compared to baseline.
Muscle function on tissue biopsy Week 0; Week 12 Mitochondrial respiration of muscle histology. Expressed as pmol/s/ml.
LDLox Week 0; Week 6; Week 12 oxydized LDL. Expressed as pg/ml, variation (pg/l and %) compared to baseline.
ApoB Week 0; Week 12 Circulating ApoLipoprotein B. Expressed as g/ml. variation (g/l and %) compared to baseline.
CK Week 0; Week 12 Creatin kinase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
AST Week 0; Week 12 Aspartate transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
usCRP Week 0; Week 12 ultrasensible C-reactiv protein. Expressed as mg/l. variation (mg/l and %) compared to baseline.
Creatinin Week 0; Week 12 Creatinin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
VO2 MAX Week 0; Week 6; Week 12 VO2MAX. Expressed as ml/min/kg. variation (ml/min/kg and %) compared to baseline.
Fat mass Week 0; Week 12 Fat Mass measured by DEXA. Expressed as % body mass. variation (%) compared to baseline.
Bilirubin Week 0; Week 12 Bilirubin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
Total Protein Week 0; Week 12 Total Protein. Expressed as g/l. variation (g/l and %) compared to baseline.
Max Strength Week 0; Week 6; Week 12 Max grip strength. Expressed as N. variation (N and %) compared to baseline.
Trial Locations
- Locations (4)
Clermont Université, Université Blaise Pascal, EA 3533, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), BP 10448
🇫🇷Clermont-ferrand, France
CRNH-Auvergne
🇫🇷Clermont-Ferrand, France
Clinique de cardiopneumologie de DURTOL
🇫🇷Durtol, France
Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied
🇫🇷Clermont-Ferrand, France