Effect of Allulose on Diet-induced Thermogenesis

NCT ID: NCT06515340

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-03-24

Brief Summary

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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

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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

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Diet Induced Thermogenesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Allulose Dose 1

Treatment

Group Type EXPERIMENTAL

Allulose Dose 1

Intervention Type OTHER

5 gram consumed orally

Allulose Dose 2

Treatment

Group Type EXPERIMENTAL

Allulose Dose 2

Intervention Type OTHER

10 gram consumed orally

Allulose Dose 3

Treatment

Group Type EXPERIMENTAL

Allulose Dose 3

Intervention Type OTHER

20 gram consumed orally

Interventions

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Allulose Dose 1

5 gram consumed orally

Intervention Type OTHER

Allulose Dose 2

10 gram consumed orally

Intervention Type OTHER

Allulose Dose 3

20 gram consumed orally

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anderson Advanced Ingredients

INDUSTRY

Sponsor Role collaborator

Toronto Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Nick Bellissimo, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nick Bellissimo

Role: PRINCIPAL_INVESTIGATOR

Toronto Metropolitan University

Locations

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Centre for Urban Innovation (CUI-109)

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB 2023-206 (A)

Identifier Type: -

Identifier Source: org_study_id

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