An interventional study of LIMICOL and PLACEBO in Hypercholesterolemia, sponsored by Lescuyer Laboratory. Completed at 4 sites in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Lescuyer Laboratory · Not applicable, Interventional, and Supportive care
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)
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 40 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Lescuyer Laboratory is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: LIMICOL
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.
Dietary Supplement: PLACEBO
Suplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.
Suplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.
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
Time frame: Week 12
Muscle function on tissue biopsy
Mitochondrial respiration of muscle histology. Expressed as pmol/s/ml.
Time frame: Week 0; Week 12
Total cholesterol
Total cholesterol. Expressed as g/l, variation (g/l and %) compared to baseline.
Time frame: Week 0; Week 6; Week 12
HDL-cholesterol
HDL. Expressed as g/l, variation (g/l and %) compared to baseline.
Time frame: Week 0; Week 6; Week 12
Triglycerides
Triglycerides. Expressed as g/l, variation (g/l and %) compared to baseline.
Time frame: Week 0; Week 6; Week 12
LDLox
oxydized LDL. Expressed as pg/ml, variation (pg/l and %) compared to baseline.
Time frame: Week 0; Week 6; Week 12
CoQ10
circulating coenzyme Q10. Expressed as pg/ml. variation (pg/l and %) compared to baseline.
Time frame: Week 0; Week 12
ApoA1
Circulating ApoLipoprotein A1. Expressed as g/ml. variation (g/l and %) compared to baseline.
Time frame: Week 0; Week 12
ApoB
Circulating ApoLipoprotein B. Expressed as g/ml. variation (g/l and %) compared to baseline.
Time frame: Week 0; Week 12
Glycemia
Glycemia. Expressed as mmol/l. variation (mmol/l and %) compared to baseline.
Time frame: Week 0; Week 12
Insulinemia
Insulinemia. Expressed as mUI/l. variation (mUI/l and %) compared to baseline.
Time frame: Week 0; Week 12
Myoglobin
Myoglobin. Expressed as µgI/l. variation (µg/l and %) compared to baseline.
Time frame: Week 0; Week 12
CK
Creatin kinase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Time frame: Week 0; Week 12
LD
Lactate Dehydrogenase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Time frame: Week 0; Week 12
AST
Aspartate transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Time frame: Week 0; Week 12
ALT
Alanine transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Time frame: Week 0; Week 12
ALP
Alkaline phosphatase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Time frame: Week 0; Week 12
GGT
Gamma-glutamyltransferase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Time frame: Week 0; Week 12
Bilirubin
Bilirubin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
Time frame: Week 0; Week 12
Albumin
Albumin. Expressed as g/l. variation (g/l and %) compared to baseline.
Time frame: Week 0; Week 12
Total Protein
Total Protein. Expressed as g/l. variation (g/l and %) compared to baseline.
Time frame: Week 0; Week 12
usCRP
ultrasensible C-reactiv protein. Expressed as mg/l. variation (mg/l and %) compared to baseline.
Time frame: Week 0; Week 12
Creatinin
Creatinin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
Time frame: Week 0; Week 12
Urea
Urea. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
Time frame: Week 0; Week 12
VO2 MAX
VO2MAX. Expressed as ml/min/kg. variation (ml/min/kg and %) compared to baseline.
Time frame: Week 0; Week 6; Week 12
Max Strength
Max grip strength. Expressed as N. variation (N and %) compared to baseline.
Time frame: Week 0; Week 6; Week 12
Weight
Body Weight. Expressed as Kg. variation (Kg and %) compared to baseline.
Time frame: Week 0; Week 6; Week 12
Fat mass
Fat Mass measured by DEXA. Expressed as % body mass. variation (%) compared to baseline.
Time frame: Week 0; Week 12
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lescuyer Laboratory