Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-05 @ 4:33 AM
Study NCT ID:
NCT01877460
Status:
COMPLETED
Last Update Posted:
2013-06-13
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-12', 'studyFirstSubmitDate': '2013-06-06', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood Glucose Change', 'timeFrame': '0, 10, 20, 30, 45, 60, 75, 90 and 120 min (pre-meal) and 140, 170, 200, 230 and 260 min (post-meal) after consumption of the treatments', 'description': 'Pre-meal changes from 0 min; Post-meal changes from 120 min\n\nBlood glucose (mmol/L) was measured using finger prick capillary blood sample.'}, {'measure': 'Serum Insulin Change', 'timeFrame': '0, 30, 60, 120 (pre-meal), and 140, 170 and 200 min (post-meal) after consumption of treatments', 'description': 'Pre-meal changes from 0 min; Post-meal changes from 120 min\n\nSerum insulin (μU/mL) was measured using finger prick capillary blood sample.'}], 'primaryOutcomes': [{'measure': 'Satiety Change', 'timeFrame': '0, 10, 20, 30, 45, 60, 75, 90 and 120 min (pre-meal) and 140, 170, 200, 230 and 260 min (post-meal) after consumption of the treatments', 'description': 'Pre-meal changes from 0 min; Post-meal changes from 120 min\n\nSatiety scores (mm) were assessed using 100-mm "Motivation to Eat" visual analog scale questionnaires. A composite score of the four appetite questions, including Desire to Eat, Hunger, Fullness and Prospective Food Consumption, in the "Motivation to Eat" visual analog scale was calculated to obtain the average appetite score for statistical analysis.'}], 'secondaryOutcomes': [{'measure': 'Food Intake', 'timeFrame': '120 min', 'description': 'Food intake (kCal) was assessed 120 min after consumption of the treatments, using an ad libitum pizza lunch meal. Participants were asked to eat, during a 20-min period, until feeling comfortably full.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sodium alginate', 'chocolate milk', 'satiety', 'energy intake', 'glycemia', 'insulinemia'], 'conditions': ['Health', 'Appetite Regulation', 'Glucose Metabolism']}, 'descriptionModule': {'briefSummary': 'This study compares the effects of isovolumetric (325 ml) preloads of chocolate milk supplemented with sodium alginates at incremental doses on inter-meal glucose levels, appetite scores and food intake in healthy adult men. The findings of this study will illustrate whether the addition of sodium alginate to chocolate milk will improve the glycemic properties of chocolate milk and will potentiate its satiating characteristics. This study will also elucidate whether sodium alginates, incorporated into chocolate milk, will influence glycemia, appetite sensations and food intake in a dose-dependent manner. It is hypothesized that there will be a synergy between milk and sodium alginate beyond either alone. When combined with milk components, sodium alginate is expected to improve glycemia and induce satiety more than does either milk alone or alginate alone.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy,\n* non-smoking male subjects,\n* aged 20-30 years with a body mass index between 20 and 24.9 kg/m2, were recruited.\n\nExclusion Criteria:\n\n* Breakfast skippers,\n* smokers,\n* dieters,\n* individuals with lactose-intolerance or\n* who are allergic to milk,\n* individuals with gastrointestinal problems and\n* individuals with diabetes or other metabolic diseases were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT01877460', 'briefTitle': 'Sodium Alginate in Chocolate Milk, Satiety and Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'The Effects of Isovolumetric Preloads of Sodium Alginate-enriched Chocolate Milk on Glycemia, Subjective Appetite and Food Intake in Healthy Young Men', 'orgStudyIdInfo': {'id': '26942'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium alginate-free chocolate milk', 'description': 'Sodium alginate-free chocolate milk (1% fat) (Beatrice Ltd., Toronto, Ontario)', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': '1.25% sodium alginate chocolate milk', 'description': 'Chocolate milk (Beatrice Ltd., Toronto, Ontario) with 1.25% sodium alginate', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': '2.5% sodium alginate chocolate milk', 'description': 'Chocolate milk (Beatrice Ltd., Toronto, Ontario) with 2.5% sodium alginate', 'interventionNames': ['Other: Dietary intervention']}, {'type': 'EXPERIMENTAL', 'label': '2.5% sodium alginate milk-free water-based solution', 'description': 'Water solution with 2.5% sodium alginate', 'interventionNames': ['Other: Dietary intervention']}], 'interventions': [{'name': 'Dietary intervention', 'type': 'OTHER', 'description': 'All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.', 'armGroupLabels': ['1.25% sodium alginate chocolate milk', '2.5% sodium alginate chocolate milk', '2.5% sodium alginate milk-free water-based solution', 'Sodium alginate-free chocolate milk']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 3E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Nutritional Sciences, FitzGerald Building', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'G. Harvey Anderson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'G. Harvey Anderson', 'investigatorAffiliation': 'University of Toronto'}}}}