Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00931151
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2009-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-22', 'studyFirstSubmitDate': '2009-07-01', 'studyFirstSubmitQcDate': '2009-07-01', 'lastUpdatePostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial dysfunction', 'timeFrame': '0-2-4-6 hours (after meal ingestion)'}], 'secondaryOutcomes': [{'measure': 'Postprandial inflammation', 'timeFrame': '0-0.5-1-1.5-2-3-4-6 hours (after meal ingestion)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Overweight']}, 'referencesModule': {'references': [{'pmid': '29878266', 'type': 'DERIVED', 'citation': 'Pujos-Guillot E, Brandolini-Bunlon M, Fouillet H, Joly C, Martin JF, Huneau JF, Dardevet D, Mariotti F. Metabolomics Reveals that the Type of Protein in a High-Fat Meal Modulates Postprandial Mitochondrial Overload and Incomplete Substrate Oxidation in Healthy Overweight Men. J Nutr. 2018 Jun 1;148(6):876-884. doi: 10.1093/jn/nxy049.'}, {'pmid': '26491119', 'type': 'DERIVED', 'citation': 'Mariotti F, Valette M, Lopez C, Fouillet H, Famelart MH, Mathe V, Airinei G, Benamouzig R, Gaudichon C, Tome D, Tsikas D, Huneau JF. Casein Compared with Whey Proteins Affects the Organization of Dietary Fat during Digestion and Attenuates the Postprandial Triglyceride Response to a Mixed High-Fat Meal in Healthy, Overweight Men. J Nutr. 2015 Dec;145(12):2657-64. doi: 10.3945/jn.115.216812. Epub 2015 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'Dietary protein differing by their amino acid composition could modulate undesirable metabolic and functional responses to a meal rich in saturated fat and sugars. This study aims at examining the specific effects of dairy protein with different cysteine contents on the postprandial undesirables effects elicited by the ingestion of a high fat meal in overweight subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 25 and 30\n* Waist circumference \\> 94 cm\n\nExclusion Criteria:\n\n* Allergy to milk protein\n* Abusive drug consumption\n* Smoking\n* Hypertension, diabetes\n* High level of physical activity'}, 'identificationModule': {'nctId': 'NCT00931151', 'briefTitle': 'Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects', 'organization': {'class': 'OTHER', 'fullName': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}, 'orgStudyIdInfo': {'id': 'SURPROL 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Casein', 'description': 'Protein source in the high fat meal is casein', 'interventionNames': ['Dietary Supplement: Postprandial metabolic and functional measures']}, {'type': 'EXPERIMENTAL', 'label': 'Milk soluble protein', 'description': 'Protein source in the high fat meal are milk soluble protein', 'interventionNames': ['Dietary Supplement: Postprandial metabolic and functional measures']}, {'type': 'EXPERIMENTAL', 'label': 'Alpha lactalbumin', 'description': 'Protein source in the high fat meal is alpha-lactalbumin', 'interventionNames': ['Dietary Supplement: Postprandial metabolic and functional measures']}], 'interventions': [{'name': 'Postprandial metabolic and functional measures', 'type': 'DIETARY_SUPPLEMENT', 'description': 'After ingestion of a high fat meal containing the different protein sources, the subjects undergo a series of measures of endothelial dysfunction and blood and urine sampling for the assessment of proinflammatory cytokines levels and metabolomics determinations.', 'armGroupLabels': ['Alpha lactalbumin', 'Casein', 'Milk soluble protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93', 'city': 'Bobigny', 'country': 'France', 'facility': 'Centre de recherche sur volontaires', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'overallOfficials': [{'name': 'Robert Benamouzig, MD, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Agency, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Benamouzig', 'investigatorAffiliation': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}}}}