Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT07231133
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Within-Meal Consumption of Allulose on Diet-induced Thermogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C003243', 'term': 'psicose'}, {'id': 'C012043', 'term': 'stevioside'}, {'id': 'C026285', 'term': 'trichlorosucrose'}, {'id': 'D062407', 'term': 'Meals'}], 'ancestors': [{'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': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, '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': '2025-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diet-Induced Thermogenesis', 'timeFrame': 'Collected at baseline (before treatment consumption) and 30-min intervals for 5 hours post-treatment consumption.', 'description': 'Before treatment consumption, participants will be rested in a supine position for 30 min to reach a steady resting state in an isolated, dimly lit room under controlled temperature and humidity conditions. Resting energy expenditure (REE) will be determined by indirect calorimetry (ParvoMedics TrueOne2400 automated metabolic gas analysis system, ParvoMedics, Sandy, UT, USA) under a ventilated hood for 30 min. Post-treatment consumption, respiratory gases will be measured in 30 min intervals for 5 hours under the ventilated hood using the indirect calorimeter, with a 30 min rest break between measurements. Diet-induced thermogenesis (kcal/h) will be calculated as the increase in energy expenditure above baseline REE over the duration of the measurements.'}], 'secondaryOutcomes': [{'measure': 'Substrate Oxidation', 'timeFrame': 'Collected at baseline (before treatment consumption) and 30-min intervals for 5 hours post-treatment consumption.', 'description': 'During the assessment of diet-induced thermogenesis via indirect calorimetry, respiratory exchange ratio will be monitored to assess the effects on substrate utilization. Energy expenditure and substrate oxidation rates for each hourly interval will be calculated using average VO2 and VCO2 measurements.'}, {'measure': 'Blood Glucose', 'timeFrame': 'Collected at baseline (before treatment consumption) and 15-min intervals for 5 hours post-treatment consumption.', 'description': 'Blood glucose concentrations will be collected using the Freestyle Libre 2 Continuous Glucose Monitoring system, which collects glucose measurements from the interstitial fluid. The sensor will be scanned to provide blood glucose data every 15 minutes, which will be used to evaluate glycemic response over the duration of each session. Continuous glucose monitors will be inserted by the participants on their upper arm following the manufacturer instructions and with the assistance of a trained research assistant.'}, {'measure': 'Subjective Appetite', 'timeFrame': 'Collected at baseline (before treatment consumption) and 30 min intervals for 5 hours post-treatment consumption.', 'description': 'Measured using visual analogue scales (VAS). Each VAS is a 100 mm line where they will place a pencil mark to describe their feelings. Questions will include desire to eat, fullness, hunger, and prospective food consumption. Individual questions will be used to form a composite score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adults', 'Allulose', 'Non nutritive sweeteners', 'Energy expenditure', 'Blood glucose', 'Appetite'], 'conditions': ['Diet Induced Thermogenesis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the within-meal effects of allulose compared to sucralose and stevia on diet-induced thermogenesis, substrate oxidation, glycemic response, and subjective appetite in healthy normal weight adults.', 'detailedDescription': 'A within-subject, repeated measures, randomized, repeated measures design will be used. Participants (n=10, 5 males, 5 females) will consume, in a random order, one of four test treatments on 4 separate days: (1) meal alone, (2) allulose + meal, (3) sucralose + meal or (4) stevia + meal. The allulose, sucralose, and stevia component of the treatment will be matched for sweetness. The dose of allulose will be confirmed in another study that will be completed prior to the start of the present study. The allulose, sucralose and stevia component of the treatment will be consumed 15 minutes prior to the breakfast meal, followed by the meal being consumed within 30 minutes. After treatment consumption, energy expenditure measurements via indirect calorimetry will be collected in 30-min increments (30-min measurement, 30-min rest) for 5 hours. Blood glucose will be measured at baseline and continuously for 5 hours via the Freestyle Libre 2 continuous glucose monitoring system. Subjective appetite (hunger, fullness, desire to eat, prospective food consumption) will be measured via visual analogue scales at baseline and at the end of each energy expenditure measurement over 5 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Participants (18 - 45 years) who are considered healthy, are non-smokers, and have a body mass index (BMI) between 20 and 24.9 kg/m2 \\[World Health Organization classification of normal weight BMI\\].\n\nExclusion Criteria:\n\n* Participants who have a fasting plasma glucose \\> 5.5 mmol/L indicative of impaired fasting glucose, previously diagnosed diabetes, known or uncertain pregnancy status at the screening visit, gastrointestinal disease, liver or kidney disease, have undergone a major medical or surgical event within the past 6 months, were or are on a diet, skip breakfast, smoke or have taken medication which would be a potential confounder with effects on metabolic and intake regulation.\n* Those unable to complete the testing protocols or are intolerant or allergic to test-day ingredients.'}, 'identificationModule': {'nctId': 'NCT07231133', 'briefTitle': 'Effect of Within-Meal Consumption of Allulose on Diet-induced Thermogenesis', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Metropolitan University'}, 'officialTitle': 'Effect of Within-Meal Consumption of Allulose Compared to Sucralose and Stevia on Diet-induced Thermogenesis, Substrate Oxidation, Glycemic Response, and Satiety in Normal Weight Adults', 'orgStudyIdInfo': {'id': 'REB 2023-206 (B)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allulose', 'description': 'Treatment', 'interventionNames': ['Other: Allulose']}, {'type': 'EXPERIMENTAL', 'label': 'Stevia', 'description': 'Treatment', 'interventionNames': ['Other: Stevia']}, {'type': 'EXPERIMENTAL', 'label': 'Sucralose', 'description': 'Treatment', 'interventionNames': ['Other: Sucralose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Meal alone', 'description': 'Control', 'interventionNames': ['Other: Meal']}], 'interventions': [{'name': 'Allulose', 'type': 'OTHER', 'description': 'Within meal consumption of Allulose (20 g)', 'armGroupLabels': ['Allulose']}, {'name': 'Stevia', 'type': 'OTHER', 'description': 'Within meal consumption of Stevia (0.0481 g). Matched for sweetness with Allulose treatment.', 'armGroupLabels': ['Stevia']}, {'name': 'Sucralose', 'type': 'OTHER', 'description': 'Within meal consumption of Sucralose (0.0238 g). Matched for sweetness with Allulose treatment.', 'armGroupLabels': ['Sucralose']}, {'name': 'Meal', 'type': 'OTHER', 'description': 'Control treatment. Meal consumed alone.', 'armGroupLabels': ['Meal alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Metropolitan University', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Nick Bellissimo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Metropolitan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anderson Advanced Ingredients', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nick Bellissimo, PhD', 'investigatorAffiliation': 'Toronto Metropolitan University'}}}}