NCT06315725Terminated
Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D)
A Randomized Cross-Over Study to Investigate the Effect of the Non-Nutritive Sweetener Sucralose on Glucose Metabolism in Patients With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 3 (actual)
- First submitted
- 12 Mar 2024
- Start date
- 12 Nov 2024
- Primary completion date
- 22 Sept 2026
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- Type 1 diabetes
- NCT number
- NCT06315725
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Alcohol or substance use disorder,
- Eating disorder or history of malabsorptive syndrome,
- Inflammatory bowel disease,
- Self-reported impairment in taste or smell,
- Food allergies or intolerances,
- History of bariatric surgery at any point in the past ●. Regular consumer of Gymnema sylvestre
Other
- A major medical diagnosis that could potentially influence metabolic dysfunction
- A major medical diagnosis other than T1D,
- A known taste or smell dysfunction (e.g., anosmia),
- Active pregnancy and/or lactation,
- Dislike of the test beverages,
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Innovative Medicine, The Research Institute of the McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.