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

Toronto Metropolitan University

Status: Completed

Conditions: Diet Induced Thermogenesis

Treatments: Other: Stevia; Other: Sucralose; Other: Meal; Other: Allulose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07231133

REB 2023-206 (B)

Details and patient eligibility

About

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.

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 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.

Enrollment: 12 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

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12 participants in 4 patient groups, including a placebo group

Allulose

Experimental group

Description:

Treatment

Treatment:

Other: Allulose

Stevia

Experimental group

Description:

Treatment

Treatment:

Other: Stevia

Sucralose

Experimental group

Description:

Treatment

Treatment:

Other: Sucralose

Meal alone

Placebo Comparator group

Description:

Control

Treatment:

Other: Meal