Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function. (L2012-12)

Effect of the Food Supplement LIMICOL on LDL Cholesterol and Muscle Function in Subjects Who Undergo a Program of Physical Training (Double-blind, Randomized, Placebo-controlled Study).

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)

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: LIMICOL; Dietary supplement: PLACEBO

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, F-63001
    • CRNH-Auvergne
  • Clermont-Ferrand, France, F-63003
    • Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied
  • Clermont-ferrand, France, F-63000
    • Clermont Université, Université Blaise Pascal, EA 3533, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), BP 10448
  • Durtol, France, F-63830
    • Clinique de cardiopneumologie de DURTOL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: LIMICOL; Suplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.
Placebo Comparator: 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.	Dietary supplement: PLACEBO; Suplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Lescuyer Laboratory
• Collaborators: Université d'Auvergne; Hopital Gabriel Montpied; CRNH Auvergne; Clinique Médicale Cardio-Pneumologie de Durtol
• Investigators: Principal Investigator: Martine Duclos, Pr, CHU G. Montpied

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: September 8, 2014
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hypercholesterolemia; LDL cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 2013-A00061-44