Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01272427
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2011-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucose, Whey Protein and Time to the Next Meal on Mealtime Food Intake in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-13', 'studyFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake (kcal)', 'timeFrame': '30 and 60 min after the treatment'}], 'secondaryOutcomes': [{'measure': 'subjective appetite', 'timeFrame': '0-120 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that glucose and whey protein given 30 and 60 min before a pizza meal will exert different effects on food intake in adolescent children, and will depend on pubertal stage. Food intake will be measured at 30 and 60 min following a glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or sweetened noncaloric beverage. Subjective appetite will be measured as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with no emotional, behavioral or learning problems\n\nExclusion Criteria:\n\n* underweight children\n* children with emotional, behavioral or learning problems\n* children who dislike foods in study'}, 'identificationModule': {'nctId': 'NCT01272427', 'briefTitle': 'Glucose, Whey Protein and Time to the Next Meal on Mealtime Food Intake in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'The Effect of Glucose, Whey Protein and Time to the Next Meal on Food Intake and Subjective Appetite in Normal Weight and Overweight/Obese Children', 'orgStudyIdInfo': {'id': 'FoodIntakeKids_21595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'noncaloric beverage', 'description': 'noncaloric sweetened beverage administered 30 min prior to mealtime', 'interventionNames': ['Dietary Supplement: water with noncaloric sweetener']}, {'type': 'EXPERIMENTAL', 'label': 'noncaloric beverage (60 min)', 'description': 'noncaloric sweetened beverage administered 60 min prior to mealtime', 'interventionNames': ['Dietary Supplement: water with noncaloric sweetener']}, {'type': 'EXPERIMENTAL', 'label': 'glucose beverage', 'description': 'glucose beverage administered 30 min prior to mealtime', 'interventionNames': ['Dietary Supplement: water with glucose']}, {'type': 'EXPERIMENTAL', 'label': 'glucose beverage (60 min)', 'description': 'glucose beverage administered 60 min prior to mealtime', 'interventionNames': ['Dietary Supplement: water with glucose']}, {'type': 'EXPERIMENTAL', 'label': 'whey protein beverage', 'description': 'whey protein beverage administered 30 min prior to mealtime', 'interventionNames': ['Dietary Supplement: water and whey protein']}, {'type': 'EXPERIMENTAL', 'label': 'whey protein beverage (60 min)', 'description': 'whey protein beverage administered 60 min prior to mealtime', 'interventionNames': ['Dietary Supplement: water and whey protein']}], 'interventions': [{'name': 'water with glucose', 'type': 'DIETARY_SUPPLEMENT', 'description': '0.75 g/kg body weight of glucose added to water', 'armGroupLabels': ['glucose beverage', 'glucose beverage (60 min)']}, {'name': 'water and whey protein', 'type': 'DIETARY_SUPPLEMENT', 'description': '0.75 g/kg body weight of whey protein added to water', 'armGroupLabels': ['whey protein beverage', 'whey protein beverage (60 min)']}, {'name': 'water with noncaloric sweetener', 'type': 'DIETARY_SUPPLEMENT', 'description': '0.15 g of sucralose added to water', 'armGroupLabels': ['noncaloric beverage', 'noncaloric beverage (60 min)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Nutritional Sciences', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Harvey Anderson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'G. Harvey Anderson', 'investigatorAffiliation': 'University of Toronto'}}}}