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Effect of Allulose on Diet-induced Thermogenesis

T

Toronto Metropolitan University

Status

Completed

Conditions

Diet Induced Thermogenesis

Treatments

Other: Allulose Dose 2
Other: Allulose Dose 1
Other: Allulose Dose 3

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06515340
REB 2023-206 (A)

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

11 participants in 3 patient groups

Allulose Dose 1
Experimental group
Description:
Treatment
Treatment:
Other: Allulose Dose 1
Allulose Dose 2
Experimental group
Description:
Treatment
Treatment:
Other: Allulose Dose 2
Allulose Dose 3
Experimental group
Description:
Treatment
Treatment:
Other: Allulose Dose 3

Trial contacts and locations

1

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Central trial contact

Nick Bellissimo

Data sourced from clinicaltrials.gov

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