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NCT06315725 | RECRUITING | Type 1 Diabetes (T1D)

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

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

Information provided by (Responsible Party):

Dana Small

Brief 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.

Condition or disease

Type 1 Diabetes (T1D)

Healthy Subjects

Intervention/treatment

Sweet taste perception with/without sweet taste blockade

Study Type : OBSERVATIONAL
Estimated Enrollment : 25 participants
Official Title : A Randomized Cross-Over Study to Investigate the Effect of the Non-Nutritive Sweetener Sucralose on Glucose Metabolism in Patients with Type 1 Diabetes
Actual Study Start Date : 2024-11-12
Estimated Primary Completion Date : 2025-11-01
Estimated Study Completion Date : 2027-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients with Type 1 Diabetes (T1D)

Location Details

NCT06315725

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Locations

RECRUITING

Canada, Quebec

Center for Innovative Medicine, The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1