Clinical trial NCT06515340: Effect of Allulose on Diet-induced Thermogenesis
Official title: Effect of Allulose on Diet-induced Thermogenesis, Substrate Oxidation, Glycemic Response, and Satiety in Normal Weight Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet Induced Thermogenesis
Keywords: Adults
Allulose
Energy expenditure
Blood glucose
Appetite
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Anderson Advanced Ingredients
First posted: 2024-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diet-induced thermogenesis
timeFrame: Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.
Secondary outcomes:
measure: Substrate oxidation
timeFrame: Collected at baseline (before treatment consumption) and 30-min intervals for 3 hours post-treatment consumption.
measure: Glycemic response
timeFrame: Collected at baseline (before treatment consumption) and 5-min intervals for 3 hours post-treatment consumption.
measure: Subjective appetite
timeFrame: Collected at baseline (before treatment consumption) and 30 min intervals for 3 hours post-treatment consumption.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Urban Innovation (CUI-109)
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Nick Bellissimo
role: PRINCIPAL_INVESTIGATOR
References: