Clinical trial NCT05750602: Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
LDL cholesterol
Lead sponsor: Lescuyer Laboratory
Sponsor class: INDUSTRY
Collaborators: name: Hopital Gabriel Montpied
name: Centre de Recherche en Nutrition Humaine d'Auvergne
name: Clinique Médicale Cardio-Pneumologie de Durtol
name: Université d'Auvergne
First posted: 2023-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)


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

Primary outcomes:
measure: LDL-cholesterol levels (g/l) at the end of study
timeFrame: Week 12
Secondary outcomes:
measure: Muscle function on tissue biopsy
timeFrame: Week 0; Week 12
measure: Total cholesterol
timeFrame: Week 0; Week 6; Week 12
measure: HDL-cholesterol
timeFrame: Week 0; Week 6; Week 12
measure: Triglycerides
timeFrame: Week 0; Week 6; Week 12
measure: LDLox
timeFrame: Week 0; Week 6; Week 12
measure: CoQ10
timeFrame: Week 0; Week 12
measure: ApoA1
timeFrame: Week 0; Week 12
measure: ApoB
timeFrame: Week 0; Week 12
measure: Glycemia
timeFrame: Week 0; Week 12
measure: Insulinemia
timeFrame: Week 0; Week 12
measure: Myoglobin
timeFrame: Week 0; Week 12
measure: CK
timeFrame: Week 0; Week 12
measure: LD
timeFrame: Week 0; Week 12
measure: AST
timeFrame: Week 0; Week 12
measure: ALT
timeFrame: Week 0; Week 12
measure: ALP
timeFrame: Week 0; Week 12
measure: GGT
timeFrame: Week 0; Week 12
measure: Bilirubin
timeFrame: Week 0; Week 12
measure: Albumin
timeFrame: Week 0; Week 12
measure: Total Protein
timeFrame: Week 0; Week 12
measure: usCRP
timeFrame: Week 0; Week 12
measure: Creatinin
timeFrame: Week 0; Week 12
measure: Urea
timeFrame: Week 0; Week 12
measure: VO2 MAX
timeFrame: Week 0; Week 6; Week 12
measure: Max Strength
timeFrame: Week 0; Week 6; Week 12
measure: Weight
timeFrame: Week 0; Week 6; Week 12
measure: Fat mass
timeFrame: Week 0; Week 12
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: Clermont Université, Université Blaise Pascal, EA 3533, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), BP 10448
city: Clermont-Ferrand
country: France
facility: CRNH-Auvergne
city: Clermont-Ferrand
country: France
facility: Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied
city: Durtol
country: France
facility: Clinique de cardiopneumologie de DURTOL
Study officials:
affiliation: CHU G. Montpied
name: Martine Duclos, Pr
role: PRINCIPAL_INVESTIGATOR
References: