Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-01-13 @ 7:55 AM
Study NCT ID:
NCT02465151
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Optimal Amount of Proteins at Breakfast for Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole body protein balance (g protein/9 hours) by nitrogen balance technique', 'timeFrame': '9 hours following ingestion of investigational product'}], 'secondaryOutcomes': [{'measure': 'Whole body protein balance (g protein/24 hours) by nitrogen balance technique', 'timeFrame': '24 hours following ingestion of investigational product'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Children']}, 'referencesModule': {'references': [{'pmid': '30053279', 'type': 'DERIVED', 'citation': 'Karagounis LG, Volterman KA, Breuille D, Offord EA, Emady-Azar S, Moore DR. Protein Intake at Breakfast Promotes a Positive Whole-Body Protein Balance in a Dose-Response Manner in Healthy Children: A Randomized Trial. J Nutr. 2018 May 1;148(5):729-737. doi: 10.1093/jn/nxy026.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to identify how much protein is required at breakfast to promote positive whole body protein balance over the following 9h period.', 'detailedDescription': 'This study will be the first to establish the role of eating protein at breakfast on whole body protein balance in healthy children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 7-12 years of age\n* Healthy and recreationally physically active (obtaining a 3- day average moderate/vigorous physical activity of at least 30 min/day)\n* Body mass at ≥10th percentile for 7 year olds and ≤85th percentile for 12 year olds. Values based upon 2000 CDC Growth Charts for the United States\n* Having obtained his/her informed assent\n* Having obtained his/her consent from parent or legal guardian\n* Being able to communicate in local language\n* Have a habitual daily protein consumption of between 1.6 g/kg and 2.4 g/kg/bw\n\nExclusion Criteria:\n\n* Self-report on regular medication impacting the metabolism, such as corticoids, hormone (e.g thyroid, adrenal) treatment, or medication against diabetes or against hypercholesterolemia or hypertriglyceridemia\n* Self-reported history of metabolic, hepatic or renal disease\n* Self-reported allergy to milk proteins (e.g., whey or casein) or intolerance to any food ingredients to be used in the study products and meals\n* Within 1.5 years of estimated age of peak height velocity (PHV)\n* Special diet or weight loss program (e.g Atkins diet)\n* Consuming breakfast containing more than 21g of protein on each day of the 3-d screening period\n* Subject who cannot be expected to comply with the study procedures, including unwillingness to consume study product and meals\n* Currently participating or having participated in another nutritional-clinical trial during the last 2 months prior to the beginning of this study'}, 'identificationModule': {'nctId': 'NCT02465151', 'briefTitle': 'Assessment of the Optimal Amount of Proteins at Breakfast for Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Assessment of the Optimal Amount of Proteins at Breakfast for Children', 'orgStudyIdInfo': {'id': '14.09.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No Protein', 'interventionNames': ['Other: Protein-based beverage']}, {'type': 'EXPERIMENTAL', 'label': 'Low Protein', 'interventionNames': ['Other: Protein-based beverage']}, {'type': 'EXPERIMENTAL', 'label': 'Medium Protein', 'interventionNames': ['Other: Protein-based beverage']}, {'type': 'EXPERIMENTAL', 'label': 'High Protein', 'interventionNames': ['Other: Protein-based beverage']}], 'interventions': [{'name': 'Protein-based beverage', 'type': 'OTHER', 'description': 'protein-based beverage', 'armGroupLabels': ['High Protein', 'Low Protein', 'Medium Protein', 'No Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 2C9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Goldring Centre for High Performance Sport at University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Dan Moore', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}