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

NCT ID: NCT05750602

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-09-30

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)

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

LIMICOL

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

LIMICOL

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

Intervention Type: DIETARY_SUPPLEMENT

PLACEBO

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hopital Gabriel Montpied

OTHER

Sponsor Role: collaborator

Centre de Recherche en Nutrition Humaine d'Auvergne

OTHER_GOV

Sponsor Role: collaborator

Clinique Médicale Cardio-Pneumologie de Durtol

UNKNOWN

Sponsor Role: collaborator

Université d'Auvergne

OTHER

Sponsor Role: collaborator

Lescuyer Laboratory

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine Duclos, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU G. Montpied

Locations

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, , France

Countries

France

Other Identifiers

2013-A00061-44

Identifier Type: -

Identifier Source: org_study_id