Effect of Within-Meal Consumption of Allulose on Diet-induced Thermogenesis

NCT07231133 | Completed

• 1 other identifier: REB 2023-206 (B)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet Induced Thermogenesis

Keywords

Adults; Allulose; Non nutritive sweeteners; 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 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.

  Collected at baseline (before treatment consumption) and 30-min intervals for 5 hours post-treatment consumption.

Secondary Outcomes (3)

• Substrate Oxidation

  Collected at baseline (before treatment consumption) and 30-min intervals for 5 hours post-treatment consumption.

• Blood Glucose

  Collected at baseline (before treatment consumption) and 15-min intervals for 5 hours post-treatment consumption.

• Subjective Appetite

  Collected at baseline (before treatment consumption) and 30 min intervals for 5 hours post-treatment consumption.

Study Arms (4)

Allulose

EXPERIMENTAL

Treatment

Other: Allulose

Stevia

EXPERIMENTAL

Treatment

Other: Stevia

Sucralose

EXPERIMENTAL

Treatment

Other: Sucralose

Meal alone

PLACEBO COMPARATOR

Control

Other: Meal

Interventions

Allulose OTHER

Within meal consumption of Allulose (20 g)

Allulose

Stevia OTHER

Within meal consumption of Stevia (0.0481 g). Matched for sweetness with Allulose treatment.

Stevia

Sucralose OTHER

Within meal consumption of Sucralose (0.0238 g). Matched for sweetness with Allulose treatment.

Sucralose

Meal OTHER

Control treatment. Meal consumed alone.

Meal alone

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)

Toronto Metropolitan University

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

psicose; stevioside; trichlorosucrose; Meals

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: Professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: May 6, 2025
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: November 17, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)