Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-01-11 @ 9:09 PM
Study NCT ID:
NCT07231133
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Within-Meal Consumption of Allulose on Diet-induced Thermogenesis
Sponsor:
Toronto Metropolitan University
Organization:
Study Overview
Official Title:
Effect of Within-Meal Consumption of Allulose Compared to Sucralose and Stevia on Diet-induced Thermogenesis, Substrate Oxidation, Glycemic Response, and Satiety in Normal Weight Adults
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: