Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-30 @ 9:37 AM
Study NCT ID:
NCT01598935
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2012-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-exercise Protein Intake for Active Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2012-02-16', 'studyFirstSubmitQcDate': '2012-05-11', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole body protein balance', 'timeFrame': 'Participants will be followed for 10 days prior to assessment of whole body protein balance.', 'description': 'Whole body protein balance will be measured by stable isotopes.'}], 'secondaryOutcomes': [{'measure': 'Whole body protein metabolism, metabolites', 'timeFrame': 'Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites', 'description': 'Whole body protein metabolism by stable isotopes and metabolite concentrations in plasma and urine.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Child']}, 'referencesModule': {'references': [{'pmid': '28381530', 'type': 'DERIVED', 'citation': 'Volterman KA, Moore DR, Breithaupt P, Godin JP, Karagounis LG, Offord EA, Timmons BW. Postexercise Dietary Protein Ingestion Increases Whole-Body Leucine Balance in a Dose-Dependent Manner in Healthy Children. J Nutr. 2017 May;147(5):807-815. doi: 10.3945/jn.116.239756. Epub 2017 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'Today, there is an important lack of knowledge on the effects of dietary protein on protein metabolism after physical activity in children. Here, the investigators will measure changes in whole body protein metabolism using minimally invasive techniques and stable isotope methodology at rest and after physical activity with the intake of milk protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy and physically active (as determined by medical and activity questionnaire)\n* 10-12 years of age\n* Within approximately 2 years of estimated age of peak height velocity (PHV)\n* Minimum aerobic fitness of 35 ml/kg/min as assessed by the McMaster All-out Progressive Continuous Cycling Protocol\n* Having obtained his/her informed assent\n* Having obtained his/her legal representative's informed consent\n\nExclusion Criteria:\n\n* Post-pubertal\n* Taking any medication\n* Smoker\n* Undergoing medical treatment or investigations\n* Body mass index \\> 24\n* Suffer from chronic diseases (with regular intake of drugs, medical history)\n* Vegetarians\n* Vaccination in the last 4 months\n* Any know food allergies or intolerance\n* Pregnancy\n* Special diet or weight loss program (e.g. Atkins diet)\n* Acute illness\n* Fever, cold, flu\n* Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts)."}, 'identificationModule': {'nctId': 'NCT01598935', 'briefTitle': 'Post-exercise Protein Intake for Active Children', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Double Blind Controlled Trial of Protein in Active Children', 'orgStudyIdInfo': {'id': '10.44.NRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'placebo', 'interventionNames': ['Other: nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High protein intake', 'description': 'Nutrition - High protein', 'interventionNames': ['Other: nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low protein intake', 'description': 'Nutrition - Low protein', 'interventionNames': ['Other: nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medium protein intake', 'description': 'Nutrition - Medium protein', 'interventionNames': ['Other: nutrition']}], 'interventions': [{'name': 'nutrition', 'type': 'OTHER', 'description': 'protein-based food', 'armGroupLabels': ['Control', 'High protein intake', 'Low protein intake', 'Medium protein intake']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Brian W Timmons, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nestec Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}