Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT05750602
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2014-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-cholesterol levels (g/l) at the end of study', 'timeFrame': 'Week 12', 'description': 'Effect of LIMICOL supplementation showed by ANCOVA analysis of LDL cholesterol (g/l), with baseline LDL as covariable'}], 'secondaryOutcomes': [{'measure': 'Muscle function on tissue biopsy', 'timeFrame': 'Week 0; Week 12', 'description': 'Mitochondrial respiration of muscle histology. Expressed as pmol/s/ml.'}, {'measure': 'Total cholesterol', 'timeFrame': 'Week 0; Week 6; Week 12', 'description': 'Total cholesterol. Expressed as g/l, variation (g/l and %) compared to baseline.'}, {'measure': 'HDL-cholesterol', 'timeFrame': 'Week 0; Week 6; Week 12', 'description': 'HDL. Expressed as g/l, variation (g/l and %) compared to baseline.'}, {'measure': 'Triglycerides', 'timeFrame': 'Week 0; Week 6; Week 12', 'description': 'Triglycerides. Expressed as g/l, variation (g/l and %) compared to baseline.'}, {'measure': 'LDLox', 'timeFrame': 'Week 0; Week 6; Week 12', 'description': 'oxydized LDL. Expressed as pg/ml, variation (pg/l and %) compared to baseline.'}, {'measure': 'CoQ10', 'timeFrame': 'Week 0; Week 12', 'description': 'circulating coenzyme Q10. Expressed as pg/ml. variation (pg/l and %) compared to baseline.'}, {'measure': 'ApoA1', 'timeFrame': 'Week 0; Week 12', 'description': 'Circulating ApoLipoprotein A1. Expressed as g/ml. variation (g/l and %) compared to baseline.'}, {'measure': 'ApoB', 'timeFrame': 'Week 0; Week 12', 'description': 'Circulating ApoLipoprotein B. Expressed as g/ml. variation (g/l and %) compared to baseline.'}, {'measure': 'Glycemia', 'timeFrame': 'Week 0; Week 12', 'description': 'Glycemia. Expressed as mmol/l. variation (mmol/l and %) compared to baseline.'}, {'measure': 'Insulinemia', 'timeFrame': 'Week 0; Week 12', 'description': 'Insulinemia. Expressed as mUI/l. variation (mUI/l and %) compared to baseline.'}, {'measure': 'Myoglobin', 'timeFrame': 'Week 0; Week 12', 'description': 'Myoglobin. Expressed as µgI/l. variation (µg/l and %) compared to baseline.'}, {'measure': 'CK', 'timeFrame': 'Week 0; Week 12', 'description': 'Creatin kinase. Expressed as UI/l. variation (UI/l and %) compared to baseline.'}, {'measure': 'LD', 'timeFrame': 'Week 0; Week 12', 'description': 'Lactate Dehydrogenase. Expressed as UI/l. variation (UI/l and %) compared to baseline.'}, {'measure': 'AST', 'timeFrame': 'Week 0; Week 12', 'description': 'Aspartate transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.'}, {'measure': 'ALT', 'timeFrame': 'Week 0; Week 12', 'description': 'Alanine transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.'}, {'measure': 'ALP', 'timeFrame': 'Week 0; Week 12', 'description': 'Alkaline phosphatase. Expressed as UI/l. variation (UI/l and %) compared to baseline.'}, {'measure': 'GGT', 'timeFrame': 'Week 0; Week 12', 'description': 'Gamma-glutamyltransferase. Expressed as UI/l. variation (UI/l and %) compared to baseline.'}, {'measure': 'Bilirubin', 'timeFrame': 'Week 0; Week 12', 'description': 'Bilirubin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.'}, {'measure': 'Albumin', 'timeFrame': 'Week 0; Week 12', 'description': 'Albumin. Expressed as g/l. variation (g/l and %) compared to baseline.'}, {'measure': 'Total Protein', 'timeFrame': 'Week 0; Week 12', 'description': 'Total Protein. Expressed as g/l. variation (g/l and %) compared to baseline.'}, {'measure': 'usCRP', 'timeFrame': 'Week 0; Week 12', 'description': 'ultrasensible C-reactiv protein. Expressed as mg/l. variation (mg/l and %) compared to baseline.'}, {'measure': 'Creatinin', 'timeFrame': 'Week 0; Week 12', 'description': 'Creatinin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.'}, {'measure': 'Urea', 'timeFrame': 'Week 0; Week 12', 'description': 'Urea. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.'}, {'measure': 'VO2 MAX', 'timeFrame': 'Week 0; Week 6; Week 12', 'description': 'VO2MAX. Expressed as ml/min/kg. variation (ml/min/kg and %) compared to baseline.'}, {'measure': 'Max Strength', 'timeFrame': 'Week 0; Week 6; Week 12', 'description': 'Max grip strength. Expressed as N. variation (N and %) compared to baseline.'}, {'measure': 'Weight', 'timeFrame': 'Week 0; Week 6; Week 12', 'description': 'Body Weight. Expressed as Kg. variation (Kg and %) compared to baseline.'}, {'measure': 'Fat mass', 'timeFrame': 'Week 0; Week 12', 'description': 'Fat Mass measured by DEXA. Expressed as % body mass. variation (%) compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypercholesterolemia', 'LDL cholesterol'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 25 and 35 kg/m²\n* Subject has a stable weight for at least three months before the start of the study.\n* LDL ≥ 1.50 g/L\n* 0.9 g/L ≤ triglycerides ≤ 4.00 g/L\n* Subject able and willing to comply with the protocol and agreeing to give his informed consent in writing;\n* Subject affiliated with a social security scheme\n\nExclusion Criteria:\n\n* Subject having a confirmed or suspected food allergy, notably to one of the components of the study product;\n* Subject suffering from a severe chronic condition deemed incompatible with participation in the study by the investigator\n* Subject with glaucoma\n* Subject with uretroprostatic disorder\n* Subjet anxious (score \\>9 HAD scale)\n* Subject with diabetes\n* Subjet with treatment anticoagulant'}, 'identificationModule': {'nctId': 'NCT05750602', 'acronym': 'L2012-12', 'briefTitle': 'Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lescuyer Laboratory'}, 'officialTitle': '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).', 'orgStudyIdInfo': {'id': '2013-A00061-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIMICOL', '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.\n\n1 tablet during the 3 principal meals for 12 weeks.', 'interventionNames': ['Dietary Supplement: LIMICOL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'description': 'dicalcium phosphate, calcium citrate, vegetable magnesium stearate, microcrystalline cellulose, Maltodextrin, Tricalcium phosphate, Beet powder, Yellow coloring shellac, Brown coloring shellac.\n\n1 tablet during the 3 principal meals for 12 weeks.', 'interventionNames': ['Dietary Supplement: PLACEBO']}], 'interventions': [{'name': 'LIMICOL', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Suplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.', 'armGroupLabels': ['LIMICOL']}, {'name': 'PLACEBO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Suplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.', 'armGroupLabels': ['PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'F-63000', '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", 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': 'F-63001', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CRNH-Auvergne', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': 'F-63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': 'F-63830', 'city': 'Durtol', 'country': 'France', 'facility': 'Clinique de cardiopneumologie de DURTOL', 'geoPoint': {'lat': 45.79621, 'lon': 3.05156}}], 'overallOfficials': [{'name': 'Martine Duclos, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU G. Montpied'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lescuyer Laboratory', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hopital Gabriel Montpied', 'class': 'OTHER'}, {'name': "Centre de Recherche en Nutrition Humaine d'Auvergne", 'class': 'OTHER_GOV'}, {'name': 'Clinique Médicale Cardio-Pneumologie de Durtol', 'class': 'UNKNOWN'}, {'name': "Université d'Auvergne", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}