Effect of Allulose on Diet-induced Thermogenesis
NCT Number: NCT06515340
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diet Induced Thermogenesis
Interventions: OTHER: Allulose Dose 1|OTHER: Allulose Dose 2|OTHER: Allulose Dose 3
Sponsor: Toronto Metropolitan University
Collaborators: Anderson Advanced Ingredients
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-01-01
Locations: Centre for Urban Innovation (CUI-109), Toronto, Ontario, M5B 2K3, Canada

Summary:
The objective of this study is to investigate the dose-response effect of allulose on diet-induced thermogenesis, substrate oxidation, glycemic response, and subjective appetite in healthy normal weight adults.

Primary Outcome Measures: Diet-induced thermogenesis, 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 3 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., Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.
Secondary Outcome Measures: Substrate oxidation, 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., Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.|Glycemic response, Blood glucose concentrations will be collected using the Dexcom Continuous Glucose Monitoring system, which collects glucose measurements from the interstitial fluid. The sensor will provide blood glucose data every five 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 abdomen following the manufacturer instructions and with the assistance of a trained research assistant., Collected at baseline (before treatment consumption) and 5-min intervals for 3 hours post-treatment consumption.|Subjective appetite, 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., Collected at baseline (before treatment consumption) and 30 min intervals for 3 hours post-treatment consumption.