Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:42 PM
Study NCT ID:
NCT01066260
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-03', 'studyFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2010-02-09', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy intake', 'timeFrame': 'Lunch'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Probiotics', 'Energy balance'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Changes in energy metabolism might be involved in the effects of probiotics on weight control.\n\nThe objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Masss Index (BMI) 25 - 30 kg/m2\n* Healthy (determined by medical questionnaire)\n* Able to commit to the duration of the study\n* Providing consent for participation\n\nExclusion Criteria:\n\n* History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease\n* History of gastrointestinal surgery\n* History of sleep disorders\n* Recent bacterial infection (\\< 2 weeks)\n* Weight loss \\> 5 kg in the last 3 months\n* Under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy\n* Excessive consumption of products enriched in probiotics (\\> 4 servings per week) within the last 4 weeks before the start of the study\n* History of drug or alcohol abuse (\\> 2 drinks daily)\n* Regular smokers (more than 5 cigarettes a day)\n* Not eating breakfast regularly or eating breakfast before 6h00.\n* Not willing to eat any of the foods to be served in the study for any reason\n* Physical activity level \\> 150 min of moderate or intense exercise per week\n* Concurrent or recent intervention study (within 60 days)'}, 'identificationModule': {'nctId': 'NCT01066260', 'briefTitle': 'Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects', 'orgStudyIdInfo': {'id': '09-24 MET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'interventionNames': ['Dietary Supplement: Probiotic formulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Probiotic formulation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Twice a day for 24 days', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Twice a day for 24 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Nestlé Research Center', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Maurice Beaumont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Société des Produits Nestlé (SPN)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}