Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT02197195
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2014-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-20', 'studyFirstSubmitDate': '2014-07-20', 'studyFirstSubmitQcDate': '2014-07-20', 'lastUpdatePostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Glucose (mmol/L)', 'timeFrame': 'at baseline (0), 20 and 65 minutes', 'description': 'Blood Glucose (mmol/L) determined by fingerprick glucometer reading'}], 'secondaryOutcomes': [{'measure': 'Subjective Appetite (mm)', 'timeFrame': '0 - 65 mins', 'description': 'Subjective appetite (in mm) determined by visual analogue scale will be determined at 0, 20, 35, 50 and 65 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glycemic Control', 'Subjective Appetite']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children. The investigators hypothesize that chocolate milk in combination with exercise will have the greatest effect attenuating glycaemic response. Blood glucose will be measured by finger prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65 minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, boy, born at full term and normal birth weight\n\nExclusion Criteria:\n\n* Girls, have significant learning, behavioral, or emotional difficulties'}, 'identificationModule': {'nctId': 'NCT02197195', 'briefTitle': 'Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Metropolitan University'}, 'officialTitle': 'The Role of Chocolate Milk and Fruit Drink on Subjective Appetite and Glycaemic Response With or Without Exercise in Normal Weight 9-14 Year Old Boys', 'orgStudyIdInfo': {'id': 'REB 2013-251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chocolate Milk Beverage', 'description': 'Chocolate milk beverage and sitting quietly', 'interventionNames': ['Dietary Supplement: Chocolate Milk']}, {'type': 'EXPERIMENTAL', 'label': 'Chocolate Milk Beverage and Exercise', 'description': 'Chocolate milk beverage and exercising', 'interventionNames': ['Dietary Supplement: Chocolate Milk', 'Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Fruit Drink Beverage', 'description': 'Fruit drink beverage and sitting quietly', 'interventionNames': ['Dietary Supplement: Fruit Drink']}, {'type': 'EXPERIMENTAL', 'label': 'Fruit Drink Beverage and Exercise', 'description': 'Fruit drink beverage and exercising', 'interventionNames': ['Dietary Supplement: Fruit Drink', 'Behavioral: Exercise']}], 'interventions': [{'name': 'Chocolate Milk', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Chocolate Milk Beverage', 'Chocolate Milk Beverage and Exercise']}, {'name': 'Fruit Drink', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fruit Drink Beverage', 'Fruit Drink Beverage and Exercise']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Chocolate Milk Beverage and Exercise', 'Fruit Drink Beverage and Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KHS344', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ryerson University', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Metropolitan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, School of Nutrition', 'investigatorFullName': 'Nick Bellissimo', 'investigatorAffiliation': 'Toronto Metropolitan University'}}}}