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NCT Number: NCT07231133

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

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.

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Key information

Conditions

Diet Induced Thermogenesis

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Metropolitan University

Toronto, Ontario, Canada

About this study

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 four test treatments on 4 separate days: (1) meal alone, (2) allulose + meal, (3) sucralose + meal or (4) stevia + meal. The allulose, sucralose, and stevia component of the treatment will be matched for sweetness. The dose of allulose will be confirmed in another study that will be completed prior to the start of the present study. The allulose, sucralose and stevia component of the treatment will be consumed 15 minutes prior to the breakfast meal, followed by the meal being consumed within 30 minutes. After treatment consumption, energy expenditure measurements via indirect calorimetry will be collected in 30-min increments (30-min measurement, 30-min rest) for 5 hours. Blood glucose will be measured at baseline and continuously for 5 hours via the Freestyle Libre 2 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 over 5 hours.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allulose

Other

Within meal consumption of Allulose (20 g)

Stevia

Other

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

Sucralose

Other

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

Meal

Other

Control treatment. Meal consumed alone.

Primary outcomes

  1. Diet-Induced Thermogenesis

    Time frame: Collected at baseline (before treatment consumption) and 30-min intervals for 5 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 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.

Secondary outcomes

  1. Substrate Oxidation

    Time frame: Collected at baseline (before treatment consumption) and 30-min intervals for 5 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.

  2. Blood Glucose

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

    Blood glucose concentrations will be collected using the Freestyle Libre 2 Continuous Glucose Monitoring system, which collects glucose measurements from the interstitial fluid. The sensor will be scanned to provide blood glucose data every 15 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 upper arm following the manufacturer instructions and with the assistance of a trained research assistant.

  3. Subjective Appetite

    Time frame: Collected at baseline (before treatment consumption) and 30 min intervals for 5 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.

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Collaborators

  • Anderson Advanced Ingredients

Registry information

Official study title

Effect of Within-Meal Consumption of Allulose Compared to Sucralose and Stevia on Diet-induced Thermogenesis, Substrate Oxidation, Glycemic Response, and Satiety in Normal Weight Adults

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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