Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.

Hypercholesterolemia Clinical Trial

— L2012-12  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05750602
• Other study ID #: 2013-A00061-44
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: September 2018

Study information

• Verified date: February 2023
• Source: Lescuyer Laboratory
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• LIMICOL
Suplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.
• PLACEBO
Suplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.

Locations

Country	Name	City	State
France	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	Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied	Clermont-Ferrand
France	Clinique de cardiopneumologie de DURTOL	Durtol

Sponsors (5)

Lead Sponsor	Collaborator
Lescuyer Laboratory	Clinique Médicale Cardio-Pneumologie de Durtol, CRNH Auvergne, Hopital Gabriel Montpied, Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle function on tissue biopsy	Mitochondrial respiration of muscle histology. Expressed as pmol/s/ml.	Week 0; Week 12
Secondary	Total cholesterol	Total cholesterol. Expressed as g/l, variation (g/l and %) compared to baseline.	Week 0; Week 6; Week 12
Secondary	HDL-cholesterol	HDL. Expressed as g/l, variation (g/l and %) compared to baseline.	Week 0; Week 6; Week 12
Secondary	Triglycerides	Triglycerides. Expressed as g/l, variation (g/l and %) compared to baseline.	Week 0; Week 6; Week 12
Secondary	LDLox	oxydized LDL. Expressed as pg/ml, variation (pg/l and %) compared to baseline.	Week 0; Week 6; Week 12
Secondary	CoQ10	circulating coenzyme Q10. Expressed as pg/ml. variation (pg/l and %) compared to baseline.	Week 0; Week 12
Secondary	ApoA1	Circulating ApoLipoprotein A1. Expressed as g/ml. variation (g/l and %) compared to baseline.	Week 0; Week 12
Secondary	ApoB	Circulating ApoLipoprotein B. Expressed as g/ml. variation (g/l and %) compared to baseline.	Week 0; Week 12
Secondary	Glycemia	Glycemia. Expressed as mmol/l. variation (mmol/l and %) compared to baseline.	Week 0; Week 12
Secondary	Insulinemia	Insulinemia. Expressed as mUI/l. variation (mUI/l and %) compared to baseline.	Week 0; Week 12
Secondary	Myoglobin	Myoglobin. Expressed as µgI/l. variation (µg/l and %) compared to baseline.	Week 0; Week 12
Secondary	CK	Creatin kinase. Expressed as UI/l. variation (UI/l and %) compared to baseline.	Week 0; Week 12
Secondary	LD	Lactate Dehydrogenase. Expressed as UI/l. variation (UI/l and %) compared to baseline.	Week 0; Week 12
Secondary	AST	Aspartate transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.	Week 0; Week 12
Secondary	ALT	Alanine transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.	Week 0; Week 12
Secondary	ALP	Alkaline phosphatase. Expressed as UI/l. variation (UI/l and %) compared to baseline.	Week 0; Week 12
Secondary	GGT	Gamma-glutamyltransferase. Expressed as UI/l. variation (UI/l and %) compared to baseline.	Week 0; Week 12
Secondary	Bilirubin	Bilirubin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.	Week 0; Week 12
Secondary	Albumin	Albumin. Expressed as g/l. variation (g/l and %) compared to baseline.	Week 0; Week 12
Secondary	Total Protein	Total Protein. Expressed as g/l. variation (g/l and %) compared to baseline.	Week 0; Week 12
Secondary	usCRP	ultrasensible C-reactiv protein. Expressed as mg/l. variation (mg/l and %) compared to baseline.	Week 0; Week 12
Secondary	Creatinin	Creatinin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.	Week 0; Week 12
Secondary	Urea	Urea. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.	Week 0; Week 12
Secondary	VO2 MAX	VO2MAX. Expressed as ml/min/kg. variation (ml/min/kg and %) compared to baseline.	Week 0; Week 6; Week 12
Secondary	Max Strength	Max grip strength. Expressed as N. variation (N and %) compared to baseline.	Week 0; Week 6; Week 12
Secondary	Weight	Body Weight. Expressed as Kg. variation (Kg and %) compared to baseline.	Week 0; Week 6; Week 12
Secondary	Fat mass	Fat Mass measured by DEXA. Expressed as % body mass. variation (%) compared to baseline.	Week 0; Week 12