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Completed

NCT Number: NCT05750602

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

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)

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRNH-Auvergne, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIMICOL

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. LDL-cholesterol levels (g/l) at the end of study

    Time frame: Week 12

    Effect of LIMICOL supplementation showed by ANCOVA analysis of LDL cholesterol (g/l), with baseline LDL as covariable

Secondary outcomes

  1. Muscle function on tissue biopsy

    Time frame: Week 0; Week 12

    Mitochondrial respiration of muscle histology. Expressed as pmol/s/ml.

  2. Total cholesterol

    Time frame: Week 0; Week 6; Week 12

    Total cholesterol. Expressed as g/l, variation (g/l and %) compared to baseline.

  3. HDL-cholesterol

    Time frame: Week 0; Week 6; Week 12

    HDL. Expressed as g/l, variation (g/l and %) compared to baseline.

  4. Triglycerides

    Time frame: Week 0; Week 6; Week 12

    Triglycerides. Expressed as g/l, variation (g/l and %) compared to baseline.

  5. LDLox

    Time frame: Week 0; Week 6; Week 12

    oxydized LDL. Expressed as pg/ml, variation (pg/l and %) compared to baseline.

  6. CoQ10

    Time frame: Week 0; Week 12

    circulating coenzyme Q10. Expressed as pg/ml. variation (pg/l and %) compared to baseline.

  7. ApoA1

    Time frame: Week 0; Week 12

    Circulating ApoLipoprotein A1. Expressed as g/ml. variation (g/l and %) compared to baseline.

  8. ApoB

    Time frame: Week 0; Week 12

    Circulating ApoLipoprotein B. Expressed as g/ml. variation (g/l and %) compared to baseline.

  9. Glycemia

    Time frame: Week 0; Week 12

    Glycemia. Expressed as mmol/l. variation (mmol/l and %) compared to baseline.

  10. Insulinemia

    Time frame: Week 0; Week 12

    Insulinemia. Expressed as mUI/l. variation (mUI/l and %) compared to baseline.

  11. Myoglobin

    Time frame: Week 0; Week 12

    Myoglobin. Expressed as µgI/l. variation (µg/l and %) compared to baseline.

  12. CK

    Time frame: Week 0; Week 12

    Creatin kinase. Expressed as UI/l. variation (UI/l and %) compared to baseline.

  13. LD

    Time frame: Week 0; Week 12

    Lactate Dehydrogenase. Expressed as UI/l. variation (UI/l and %) compared to baseline.

  14. AST

    Time frame: Week 0; Week 12

    Aspartate transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.

  15. ALT

    Time frame: Week 0; Week 12

    Alanine transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.

  16. ALP

    Time frame: Week 0; Week 12

    Alkaline phosphatase. Expressed as UI/l. variation (UI/l and %) compared to baseline.

  17. GGT

    Time frame: Week 0; Week 12

    Gamma-glutamyltransferase. Expressed as UI/l. variation (UI/l and %) compared to baseline.

  18. Bilirubin

    Time frame: Week 0; Week 12

    Bilirubin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.

  19. Albumin

    Time frame: Week 0; Week 12

    Albumin. Expressed as g/l. variation (g/l and %) compared to baseline.

  20. Total Protein

    Time frame: Week 0; Week 12

    Total Protein. Expressed as g/l. variation (g/l and %) compared to baseline.

  21. usCRP

    Time frame: Week 0; Week 12

    ultrasensible C-reactiv protein. Expressed as mg/l. variation (mg/l and %) compared to baseline.

  22. Creatinin

    Time frame: Week 0; Week 12

    Creatinin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.

  23. Urea

    Time frame: Week 0; Week 12

    Urea. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.

  24. VO2 MAX

    Time frame: Week 0; Week 6; Week 12

    VO2MAX. Expressed as ml/min/kg. variation (ml/min/kg and %) compared to baseline.

  25. Max Strength

    Time frame: Week 0; Week 6; Week 12

    Max grip strength. Expressed as N. variation (N and %) compared to baseline.

  26. Weight

    Time frame: Week 0; Week 6; Week 12

    Body Weight. Expressed as Kg. variation (Kg and %) compared to baseline.

  27. Fat mass

    Time frame: Week 0; Week 12

    Fat Mass measured by DEXA. Expressed as % body mass. variation (%) compared to baseline.

Sponsors and collaborators

Lead sponsor

Lescuyer Laboratory

Industry

Collaborators

  • Centre de Recherche en Nutrition Humaine d'Auvergne
  • Clinical Of Medical Cardio Pneumologie, Durtol
  • Hopital Gabriel Montpied
  • Université d'Auvergne

Registry information

Official study 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).

Acronym: L2012-12

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Mar 1, 2023
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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