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

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

Interventions

DIETARY_SUPPLEMENT

LIMICOL

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

Sponsors & Collaborators

• Hopital Gabriel Montpied

  collaborator OTHER

• Centre de Recherche en Nutrition Humaine d'Auvergne

  collaborator OTHER_GOV

• Clinique Médicale Cardio-Pneumologie de Durtol

  collaborator UNKNOWN

• Université d'Auvergne

  collaborator OTHER

• Lescuyer Laboratory

  lead INDUSTRY

Principal Investigators

• Martine Duclos, Pr · CHU G. Montpied

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2017-07-31

Completion

2018-09-30

Countries

• France

Study Locations