Effect of Allulose on Diet-induced Thermogenesis

Not Applicable

Recruiting

• Conditions: Diet Induced Thermogenesis
• Interventions: Other: Allulose Dose 2; Other: Allulose Dose 1; Other: Allulose Dose 3

• Registration Number: NCT06515340
• Lead Sponsor: Toronto Metropolitan University

Brief 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.

Detailed Description

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 three varying doses of test treatments (allulose (5g), allulose (10g) or allulose (20g)) on 3 separate days. After treatment consumption, energy expenditure measurements via indirect calorimetry will be collected in 30-min interval (30-min measurement, 30-min rest) for 3 hours. Blood glucose will be measured at baseline and continuously for 3 hours via the Dexcom G6 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 interval over 3 hours.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-15
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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].

Exclusion Criteria

• 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.
• Those unable to complete the testing protocols or are intolerant or allergic to test-day ingredients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Allulose Dose 2	Allulose Dose 2	Treatment
Allulose Dose 1	Allulose Dose 1	Treatment
Allulose Dose 3	Allulose Dose 3	Treatment

Primary Outcome Measures

Name	Time	Method
Diet-induced thermogenesis	Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.	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.

Secondary Outcome Measures

Name	Time	Method
Substrate oxidation	Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.	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.
Glycemic response	Collected at baseline (before treatment consumption) and 5-min intervals for 3 hours post-treatment consumption.	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.
Subjective appetite	Collected at baseline (before treatment consumption) and 30 min intervals for 3 hours post-treatment consumption.	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.

Trial Locations

Locations (1)

Centre for Urban Innovation (CUI-109); 🇨🇦 Toronto, Ontario, Canada