Effect of Allulose on Diet-induced Thermogenesis

Effect of Allulose on Diet-induced Thermogenesis, Substrate Oxidation, Glycemic Response, and Satiety in Normal Weight Adults

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.

Study Overview

• Status: Completed
• Conditions: Diet Induced Thermogenesis
• Intervention / Treatment: Other: Allulose Dose 1; Other: Allulose Dose 2; Other: Allulose Dose 3

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 2K3
      • Centre for Urban Innovation (CUI-109)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allulose Dose 1; Treatment	Other: Allulose Dose 1; 5 gram consumed orally
Experimental: Allulose Dose 2; Treatment	Other: Allulose Dose 2; 10 gram consumed orally
Experimental: Allulose Dose 3; Treatment	Other: Allulose Dose 3; 20 gram consumed orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Toronto Metropolitan University
• Collaborators: Anderson Advanced Ingredients
• Investigators: Principal Investigator: Nick Bellissimo, Toronto Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): March 24, 2025
• Study Completion (Actual): March 24, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Energy expenditure; Adults; Appetite; Blood glucose; Allulose
• Other Study ID Numbers: REB 2023-206 (A)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No