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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-06

Study Completion Date

2025-08-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Allulose on Diet-induced Thermogenesis

NCT06515340

Diet Induced Thermogenesis

COMPLETED NA

Effect of D-allulose in Addition to Oral Sucrose Load

NCT02714413

Blood Glucose

COMPLETED PHASE2

Comparison of the Postprandial Glycemic and Insulinemic Response of ALLSWEET When Taken Alone or When Added to Sucrose

NCT05185960

Blood Sugar

COMPLETED NA

Acute Effects of the Two Alternative Sweeteners D-allulose and Erythritol on Metabolism

NCT04027283

Physiological Satiation Mechanisms

COMPLETED NA

Preliminary Effect of Food Processing and Sweeteners on Glycemic and Metabolic Measures

NCT05658757

Blood Sugar; High Blood Pressure Dietary Habits

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diet Induced Thermogenesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Allulose

Treatment

Group Type EXPERIMENTAL

Allulose

Intervention Type OTHER

Within meal consumption of Allulose (20 g)

Stevia

Treatment

Group Type EXPERIMENTAL

Stevia

Intervention Type OTHER

Within meal consumption of Stevia (0.0481 g). Matched for sweetness with Allulose treatment.

Sucralose

Treatment

Group Type EXPERIMENTAL

Sucralose

Intervention Type OTHER

Within meal consumption of Sucralose (0.0238 g). Matched for sweetness with Allulose treatment.

Meal alone

Control

Group Type PLACEBO_COMPARATOR

Meal

Intervention Type OTHER

Control treatment. Meal consumed alone.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allulose

Within meal consumption of Allulose (20 g)

Intervention Type OTHER

Stevia

Within meal consumption of Stevia (0.0481 g). Matched for sweetness with Allulose treatment.

Intervention Type OTHER

Sucralose

Within meal consumption of Sucralose (0.0238 g). Matched for sweetness with Allulose treatment.

Intervention Type OTHER

Meal

Control treatment. Meal consumed alone.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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