Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-22 @ 10:47 AM
Study NCT ID:
NCT01755104
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
2012-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-06', 'studyFirstSubmitDate': '2012-12-18', 'studyFirstSubmitQcDate': '2012-12-18', 'lastUpdatePostDateStruct': {'date': '2014-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in visceral fat area assessed by computerized tomodensitometry', 'timeFrame': 'From baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers', 'timeFrame': 'from baseline to end of study'}, {'measure': 'Quality of life, psychological and behavioral changes', 'timeFrame': 'From baseline to end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '34341379', 'type': 'DERIVED', 'citation': 'Bel Lassen P, Belda E, Prifti E, Dao MC, Specque F, Henegar C, Rinaldi L, Wang X, Kennedy SP, Zucker JD, Calame W, Lamarche B, Claus SP, Clement K. Protein supplementation during an energy-restricted diet induces visceral fat loss and gut microbiota amino acid metabolism activation: a randomized trial. Sci Rep. 2021 Aug 2;11(1):15620. doi: 10.1038/s41598-021-94916-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m²,\n* With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria :\n\n * Arterial Blood pressure \\> or = 130 mmHg (systolic) and/or more than or equal to 85 mmHg (diastolic) or stabilized with treatment for at least 6 months,\n * Fasting glycemia \\> or = 1 g/L or 5.6 mmol/L or stabilized with treatment for at least 6 months and non-diabetic \\< 1.26 g/L,\n * Triglycerides \\> or = 1.5 g/L or 1.71 mmol/L or stabilized with treatment for at least 6 months,\n * HDL Cholesterol \\<0.40 g/L or 1.03 mmol/L (males) and \\<0,5 g/l or 1.29 mmol/L (females) or stabilized with treatment for at least 6 months.\n\nExclusion Criteria:\n\n* Pregnant (positive pregnancy test at the selection visit or breast-feeding woman,\n* Woman of childbearing potential without an efficient contraception method,\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial"}, 'identificationModule': {'nctId': 'NCT01755104', 'briefTitle': 'Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Nutrition et Cardiometabolisme'}, 'officialTitle': 'A Randomized Double-blind Placebo Controlled Trial on the Effect of Stablor™ on the Abdominal Visceral Fat Mass Loss in Patients With a Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'RCM-EFF-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stablor', 'description': 'dietary supplement Stablor', 'interventionNames': ['Dietary Supplement: Stablor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'dietary supplement Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Stablor', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Stablor']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Paris', 'country': 'France', 'facility': 'Institut CardioMetabolisme et Nutrition (ICAN)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Karine Clement, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut CardioMetabolisme et Nutrition (ICAN)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Nutrition et Cardiometabolisme', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}