Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT07230951
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interaction Between White Potato Consumption and Meal Timing on Glycemic Response and Appetite in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Response (Acute Phase)', 'timeFrame': 'Change from baseline (measured at baseline (0-minute), 15-minute, 30-minute, 60-minute, 90-minute, and 120-minute post-treatment consumption).', 'description': 'Blood glucose (mmol/L). Blood glucose concentrations will be measured using a Dexcom G7 CGM system.'}, {'measure': 'Rest-of-day Blood Glucose', 'timeFrame': 'Continuous measurements for 24 hours post-treatment consumption.', 'description': 'Blood glucose (mmol/L). Rest-of-day blood glucose concentrations will be determined using a Dexcom G7 CGM system.'}, {'measure': 'Ad Libitum Food Intake', 'timeFrame': 'At 120 minutes post-treatment consumption', 'description': 'Lunch pizza meal. Food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to calories.'}], 'secondaryOutcomes': [{'measure': 'Subjective Appetite', 'timeFrame': 'Change from baseline (measured at baseline (0-minute), 15-minute, 30-minute, 60-minute, 90-minute, and 120-minute post-treatment consumption).', 'description': 'A visual analogue scale (VAS) with four questions will be administered to assess desire to eat, fullness, hunger, and prospective food consumption. Individual questions will be used to form a composite score. Each VAS will be administered via a digital software application (Express VAS, Toronto, Ontario, Canada) on a Dell tablet where participants will place an \'X" on the VAS line (100 unit scale).'}, {'measure': 'Rest-of-day Food Intake', 'timeFrame': 'For the rest of the day following test session completion (1 day)', 'description': 'Participants will be sent home with a rest-of-the-day food intake recall sheet to record their snacks, meals, and beverages. Rest of day food log.'}, {'measure': 'Subjective Emotions', 'timeFrame': 'Change from baseline (measured at baseline (0-minute), 15-minute, 30-minute, 60-minute, 90-minute, and 120-minute post-treatment consumption).', 'description': 'A visual analogue scale (VAS) with thirteen questions will be administered to assess subjective emotions and mood (aggression, anger, excitement, disappointment, happiness, upset, frustration, alertness, sadness, tension, exhaustion, calmness, and sleepiness). Individual questions will be used to form a composite emotion score. Each VAS will be administered via a digital software application (Express VAS, Toronto, Ontario, Canada) on a Dell tablet where participants will place an \'X" on the VAS line (100 unit scale).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Adult', 'Appetite', 'Glycemic Response', 'Mealtiming']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the interaction between white potato consumption and meal timing on glycemic response, subjective appetite, and energy intake in adults. The investigators hypothesize that white potatoes will modulate glycemic response, enhance satiety, and mitigate subsequent meal consumption and overall food intake when compared with meals containing low glycemic carbohydrates. Furthermore, they anticipate that the timing of white potato consumption will yield differential effects, with breakfast consumption exerting a more pronounced impact on satiety and subsequent food intake reduction compared to dinner consumption.', 'detailedDescription': 'A randomized within-subject repeated measures experiment will be used to study the interaction between white potato consumption and meal timing on glycemic response, subjective appetite, and energy intake in adults. In Experiment 1, participants will consume, in a random order on separate mornings, one of six test meals consisting of an egg omelette and a test side of: (1) Oven-baked home fries, (2) Oven-baked white russet potatoes, (3) Deep-fried, quick serve fries, (4) Oven-baked fries, (5) Oven-baked cauliflower tots, or (6) no side. Acute glycemic response and subjective appetite will be measured at baseline and over 120-mins post treatment consumption. At 120-min, food intake will be evaluated via an ad libitum lunch. Rest of day food intake and glycemic response will be collected until the participant goes to bed. Blood glucose measurements will be collected using the Dexcom G7 continuous glucose monitoring system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 65 years\n* within the healthy body weight range \\[body mass index (BMI) between 18.5 - 24.9 kg/m2\\].\n\nExclusion Criteria:\n\n* have a previous diagnosis of diabetes and gastrointestinal, liver or kidney disease;\n* have had a major medical or surgical event within the past 6 months;\n* have had any significant weight fluctuation in the past 6-months;\n* are taking medication that may influence dependent measures;\n* are or have been on a diet within the past 6 months;\n* skip breakfast or are unable to consume test treatment food.'}, 'identificationModule': {'nctId': 'NCT07230951', 'briefTitle': 'Interaction Between White Potato Consumption and Meal Timing on Glycemic Response and Appetite in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Metropolitan University'}, 'officialTitle': 'Interaction Between White Potato Consumption and Meal Timing on Glycemic Response, Subjective Appetite, and Energy Intake in Adults.', 'orgStudyIdInfo': {'id': 'REB: 25-172 [A]'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oven-baked Home Fries', 'description': 'Test Treatment', 'interventionNames': ['Other: Oven-baked Home Fries']}, {'type': 'EXPERIMENTAL', 'label': 'Oven-baked White Russet Potato', 'description': 'Test Treatment', 'interventionNames': ['Other: Oven-baked White Russet Potato']}, {'type': 'EXPERIMENTAL', 'label': 'Oven-baked Fries', 'description': 'Test Treatment', 'interventionNames': ['Other: Oven-baked Fries']}, {'type': 'EXPERIMENTAL', 'label': 'Deep Fried, Quick Serve Fries', 'description': 'Test Treatment', 'interventionNames': ['Other: Deep Fried, Quick Serve Fries']}, {'type': 'EXPERIMENTAL', 'label': 'Oven-baked Cauliflower Veggie Tots', 'description': 'Test Treatment', 'interventionNames': ['Other: Oven-baked Cauliflower Veggie Tots']}, {'type': 'EXPERIMENTAL', 'label': 'No Side', 'description': 'Test Treatment', 'interventionNames': ['Other: No Side']}], 'interventions': [{'name': 'Oven-baked Home Fries', 'type': 'OTHER', 'description': 'Oven-baked Home Fries (241 g; McCain Ltd.). Test treatments matched for calories (284 kcal)', 'armGroupLabels': ['Oven-baked Home Fries']}, {'name': 'Oven-baked White Russet Potato', 'type': 'OTHER', 'description': 'Oven-baked White Russet Potato (299 g). Test treatments matched for calories (284 kcal)', 'armGroupLabels': ['Oven-baked White Russet Potato']}, {'name': 'Oven-baked Fries', 'type': 'OTHER', 'description': 'Oven-baked Fries (201 g; McCain Ltd.). Test treatments matched for calories (284 kcal)', 'armGroupLabels': ['Oven-baked Fries']}, {'name': 'Deep Fried, Quick Serve Fries', 'type': 'OTHER', 'description': 'Deep Fried, Quick Serve Fries (108 g; McCain Ltd.). Test treatments matched for calories (284 kcal)', 'armGroupLabels': ['Deep Fried, Quick Serve Fries']}, {'name': 'Oven-baked Cauliflower Veggie Tots', 'type': 'OTHER', 'description': 'Oven-baked Cauliflower Veggie Tots (186 g; Green Giant). Test treatments matched for calories (284 kcal)', 'armGroupLabels': ['Oven-baked Cauliflower Veggie Tots']}, {'name': 'No Side', 'type': 'OTHER', 'description': 'No side control (no caloric contribution).', 'armGroupLabels': ['No Side']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B2K3', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nick Bellissimo', 'role': 'CONTACT', 'email': 'nick.bellissimo@torontomu.ca', 'phone': '4169795000', 'phoneExt': '553103'}], 'facility': 'Centre for Urban Innovation (CUI-109), School of Nutrition, Toronto Metropolitan University', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alliance for Potato Research and Education', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nick Bellissimo, PhD', 'investigatorAffiliation': 'Toronto Metropolitan University'}}}}