Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00873951
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial metabolic fate of dietary N', 'timeFrame': '0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial'}], 'secondaryOutcomes': [{'measure': 'Differences in ileal digestibility determination according to the method used', 'timeFrame': '8h postprandial'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31711108', 'type': 'DERIVED', 'citation': 'Deglaire A, Moughan PJ, Airinei G, Benamouzig R, Tome D. Intact and hydrolyzed casein lead to similar ileal endogenous protein and amino acid flows in adult humans. Am J Clin Nutr. 2020 Jan 1;111(1):90-97. doi: 10.1093/ajcn/nqz268.'}, {'pmid': '19692493', 'type': 'DERIVED', 'citation': 'Deglaire A, Fromentin C, Fouillet H, Airinei G, Gaudichon C, Boutry C, Benamouzig R, Moughan PJ, Tome D, Bos C. Hydrolyzed dietary casein as compared with the intact protein reduces postprandial peripheral, but not whole-body, uptake of nitrogen in humans. Am J Clin Nutr. 2009 Oct;90(4):1011-22. doi: 10.3945/ajcn.2009.27548. Epub 2009 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further metabolism. The primary goal of this work was to measure the metabolic fate of intact or hydrolyzed protein using a protein of good nutritional quality, i.e., casein. A second aim of this study was to assess the true ileal digestibility of dietary protein using different methods including the hydrolyzed casein method and to measure its possible effect on endogenous intestinal N losses in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects\n* BMI between 18 and 25\n\nExclusion Criteria:\n\n* allergy to dairy proteins\n* positive serology to AgHbS, HCV or HIV\n* pregnancy\n* abusive drug or alcohol consumption.'}, 'identificationModule': {'nctId': 'NCT00873951', 'briefTitle': 'Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}, 'officialTitle': 'Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects', 'orgStudyIdInfo': {'id': 'DEGLAIRE CT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intact casein', 'description': 'Subjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as 15N-labelled intact casein', 'interventionNames': ['Other: Intestinal and metabolic exploration', 'Dietary Supplement: 15N-labelled intact casein']}, {'type': 'EXPERIMENTAL', 'label': 'Hydrolyzed casein', 'description': 'Subjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein', 'interventionNames': ['Other: Intestinal and metabolic exploration', 'Dietary Supplement: 15N-labelled hydrolyzed casein']}, {'type': 'EXPERIMENTAL', 'label': 'AA', 'description': 'Subjects undergo an intestinal and metabolic exploration following the ingestion of a standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine', 'interventionNames': ['Other: Intestinal and metabolic exploration', 'Dietary Supplement: mixture of AA']}], 'interventions': [{'name': 'Intestinal and metabolic exploration', 'type': 'OTHER', 'description': 'Subjects are studied for 8h following the ingestion of a standard meal containing 15% of energy as protein. Intestinal, blood and urine are collected at regular intervals.', 'armGroupLabels': ['AA', 'Hydrolyzed casein', 'Intact casein']}, {'name': '15N-labelled intact casein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'standard mixed meal containing 15% of energy as 15N-labelled intact casein', 'armGroupLabels': ['Intact casein']}, {'name': '15N-labelled hydrolyzed casein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'standard mixed meal containing 15% of energy as 15N-labelled hydrolyzed casein', 'armGroupLabels': ['Hydrolyzed casein']}, {'name': 'mixture of AA', 'type': 'DIETARY_SUPPLEMENT', 'description': 'standard mixed meal containing 15% of energy as a mixture of AA mimicking the composition of casein but devoid in serine', 'armGroupLabels': ['AA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93', 'city': 'Bobigny', 'country': 'France', 'facility': 'Centre de recherche sur volontaires', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}, 'collaborators': [{'name': 'Riddet Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}