Effect of Allulose on Diet-induced Thermogenesis

NCT06515340 | Completed

• 1 other identifier: REB 2023-206 (A)
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Induced Thermogenesis

Keywords

Adults; Allulose; Energy expenditure; Blood glucose; Appetite

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Substrate oxidation

  Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.

• Glycemic response

  Collected at baseline (before treatment consumption) and 5-min intervals for 3 hours post-treatment consumption.

• Subjective appetite

  Collected at baseline (before treatment consumption) and 30 min intervals for 3 hours post-treatment consumption.

Study Arms (3)

Allulose Dose 1

EXPERIMENTAL

Treatment

Other: Allulose Dose 1

Allulose Dose 2

EXPERIMENTAL

Treatment

Other: Allulose Dose 2

Allulose Dose 3

EXPERIMENTAL

Treatment

Other: Allulose Dose 3

Interventions

Allulose Dose 1 OTHER

5 gram consumed orally

Allulose Dose 1

Allulose Dose 2 OTHER

10 gram consumed orally

Allulose Dose 2

Allulose Dose 3 OTHER

20 gram consumed orally

Allulose Dose 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[World Health Organization classification of normal weight BMI\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Anderson Advanced Ingredients: collaborator

Study Sites (1)

Centre for Urban Innovation (CUI-109)

Toronto, Ontario, M5B 2K3, Canada

Location

Study Officials

• Nick Bellissimo

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: July 15, 2024
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)