Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT01812967
Status:
COMPLETED
Last Update Posted:
2013-03-18
First Post:
2013-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D007785', 'term': 'Lactose'}], 'ancestors': [{'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-03-15', 'studyFirstSubmitDate': '2013-03-13', 'studyFirstSubmitQcDate': '2013-03-15', 'lastUpdatePostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gastrointestinal hormones and gastric emptying rate', 'timeFrame': '0-180 min', 'description': 'Gatrointestinal hormones measured include plasma concentrations of glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY), cholecystokinin (CCK), and ghrelin.\n\nGastric emptying is assessed indirectly by adding 1.5 g of paracetamol (acetaminophen) to each beverage and measuring plasma paracetamol concentrations.'}], 'primaryOutcomes': [{'measure': 'Glucose', 'timeFrame': '0-180 min'}], 'secondaryOutcomes': [{'measure': 'Insulin', 'timeFrame': '0-180 min'}]}, 'conditionsModule': {'conditions': ['Glycemic Control', 'Gastrointestinal Hormone Response', 'Healthy Young Men']}, 'referencesModule': {'references': [{'pmid': '25167977', 'type': 'DERIVED', 'citation': 'Panahi S, El Khoury D, Kubant R, Akhavan T, Luhovyy BL, Goff HD, Anderson GH. Mechanism of action of whole milk and its components on glycemic control in healthy young men. J Nutr Biochem. 2014 Nov;25(11):1124-1131. doi: 10.1016/j.jnutbio.2014.07.002. Epub 2014 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy young men\n* 20-30 years of age\n* BMI: 20-24.9 kg/m2\n\nExclusion Criteria:\n\n* Smoking\n* Dieting\n* Skipping breakfast\n* Lactose intolerance or allergies to milk\n* Taking medications that may affect glucose metabolism or appetite\n* Diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases'}, 'identificationModule': {'nctId': 'NCT01812967', 'briefTitle': 'Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'orgStudyIdInfo': {'id': 'Milk Components Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Milk Fat', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'Milk Protein', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'Lactose', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'Whole milk (3.25% M.F.(', 'type': 'OTHER', 'description': 'Commercially available milk from the grocery store'}, {'name': 'Simulated Milk Beverage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Added lactose + fat + protein together to form a mixture'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'G. Harvey Anderson', 'investigatorAffiliation': 'University of Toronto'}}}}