RecruitingNot Applicable

Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients with Type 1 Diabetes (T1D)

Canada25 participantsStarted 2024-11-12

Plain-language summary

The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time. Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level. To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study. Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants with a diagnosis of T1D * HbA1C ≤ 8 % * Insulin pump therapy * Adults of any gender or biological sex aged 18-45 years old, * Body Mass Index (BMI) between 18.5-29.9 kg/m, * Non-smokers, * English or French speaker. ●. Who can consume chicken and fish Exclusion Criteria: * A major medical diagnosis that could potentially influence metabolic dysfunction * A major medical diagnosis other than T1D, * Alcohol or substance use disorder, * Eating disorder or history of malabsorptive syndrome, * Inflammatory bowel disease, * Self-reported impairment in taste or smell, * A known taste or smell dysfunction (e.g., anosmia), * Active pregnancy and/or lactation, * Food allergies or intolerances, * Dislike of the test beverages, * History of bariatric surgery at any point in the past ●. Regular consumer of Gymnema sylvestre

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals

Timeframe: from enrollment to the end of treatment at 4 weeks

Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption.

Timeframe: From enrollment to the end of treatment at 4 weeks

Trial details

NCT IDNCT06315725

SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-01

Contact for this trial

Golnaz Arjmand, PhD

514-398-3020 golnaz.arjmand@mcgill.ca

View on ClinicalTrials.gov More Type 1 Diabetes (T1D) trials