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

Lescuyer Laboratory

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: PLACEBO; Dietary Supplement: LIMICOL

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05750602

2013-A00061-44

Details and patient eligibility

About

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)

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

LIMICOL

Experimental group

Description:

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.

Treatment:

Dietary Supplement: LIMICOL

PLACEBO

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: PLACEBO