Diet Induced ThermogenesisNCT06515340
Effect of Allulose on Diet-induced Thermogenesis
A study testing Allulose Dose 1, Allulose Dose 2 and Allulose Dose 3 in people with Diet Induced Thermogenesis, run by Toronto Metropolitan University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Induced Thermogenesis
- What is being tested?
- Allulose Dose 1, Allulose Dose 2 and Allulose Dose 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2024to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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].
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Induced Thermogenesis
- Being tested
- Allulose Dose 1, Allulose Dose 2, Allulose Dose 3
- Keywords
- Adults, Allulose, Energy expenditure, Blood glucose, Appetite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allulose Dose 1Other
5 gram consumed orally
Allulose Dose 2Other
10 gram consumed orally
Allulose Dose 3Other
20 gram consumed orally
| Study group | Role | What they receive |
|---|---|---|
| Allulose Dose 1 | Experimental | Treatment Receives: Other: Allulose Dose 1 |
| Allulose Dose 2 | Experimental | Treatment Receives: Other: Allulose Dose 2 |
| Allulose Dose 3 | Experimental | Treatment Receives: Other: Allulose Dose 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Collected at baseline (before treatment consumption) and 30 min intervals for 3 hours post-treatment consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start15 Jul 2024
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet Induced ThermogenesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Anderson Advanced Ingredients
- Responsible party
- Principal investigator, Nick Bellissimo, PhD, Toronto Metropolitan University
- Investigators
- Nick Bellissimo, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515340
- Sponsor's protocol ID
- REB 2023-206 (A)
- Status last verified
- Nov 2025
- First submitted
- 17 Jul 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Allulose on Diet-induced Thermogenesis, Substrate Oxidation, Glycemic Response, and Satiety in Normal Weight Adults
- ClinicalTrials.gov ID
- NCT06515340
- Acronym / sponsor ID
- REB 2023-206 (A)
- Conditions
- Diet Induced Thermogenesis
- Keywords
- Adults, Allulose, Energy expenditure, Blood glucose, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Anderson Advanced Ingredients
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allulose Dose 1 | Experimental | Other: Allulose Dose 1Treatment |
| Allulose Dose 2 | Experimental | Other: Allulose Dose 2Treatment |
| Allulose Dose 3 | Experimental | Other: Allulose Dose 3Treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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].
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allulose Dose 15 gram consumed orally | Other | Allulose Dose 1 |
| Allulose Dose 210 gram consumed orally | Other | Allulose Dose 2 |
| Allulose Dose 320 gram consumed orally | Other | Allulose Dose 3 |
Primary outcome
Diet-induced thermogenesis
Time frame: 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.
3 secondary outcomes
Substrate oxidation
Time frame: Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.
Glycemic response
Time frame: Collected at baseline (before treatment consumption) and 5-min intervals for 3 hours post-treatment consumption.
Subjective appetite
Time frame: Collected at baseline (before treatment consumption) and 30 min intervals for 3 hours post-treatment consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Bellissimo principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allulose Dose 1, Allulose Dose 2 and Allulose Dose 3 in people with Diet Induced Thermogenesis, run by Toronto Metropolitan University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet-induced thermogenesis (time frame: Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.