Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
Study NCT ID:
NCT01025557
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-13', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake', 'timeFrame': '30 minute'}], 'secondaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': '0, 10, 20, 30, 50, 80, 110, 140 and 170 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Food intake', 'Blood glucose', 'Milk'], 'conditions': ['Diabetes Prevention', 'Obesity Prevention']}, 'descriptionModule': {'briefSummary': "The purpose of this protocol is to study the effects of fluid milk products on satiety, food intake, and glucose metabolism in healthy young men and women. Experiment 1: The specific objective is to investigate isovolumetric amounts of milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, and water (control) on satiety and food intake and on blood glucose before and after a meal. A fixed volume approach is based on the commercially available serving size. Experiment 2 will examine equicaloric amounts of milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, a glucose drink and water (control) the treatments in order to investigate macronutrient composition on satiety and food intake and on blood glucose before and after the meal."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Non-smoking\n* Aged 20-30 years\n* Body mass index between 20 and 24.9 kg/m2\n\nExclusion Criteria:\n\n* Diabetes\n* Medication\n* Lactose-intolerance or allergies to milk\n* Breakfast skippers and those on an energy restricted diet'}, 'identificationModule': {'nctId': 'NCT01025557', 'briefTitle': 'Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'The Effects of Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response in Healthy Young Men and Women', 'orgStudyIdInfo': {'id': 'Milk Study - Experiment 1'}, 'secondaryIdInfos': [{'id': 'DFO_24235'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chocolate milk', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Milk', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Infant formula', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Soy beverage', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Water', 'interventionNames': ['Other: Dietary intervention']}], 'interventions': [{'name': 'Dietary intervention', 'type': 'OTHER', 'description': 'Dietary treatments with beverages', 'armGroupLabels': ['Chocolate milk', 'Infant formula', 'Milk', 'Soy beverage', 'Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Harvey Anderson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dairy Farmers of Ontario', 'class': 'OTHER'}, {'name': 'Mondelēz International, Inc.', 'class': 'INDUSTRY'}, {'name': 'Natural Sciences and Engineering Research Council, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'G. Harvey Anderson', 'investigatorAffiliation': 'University of Toronto'}}}}