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

Last updated: November 20, 2024
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 1

Treatment

1- maltodextrin, 2- maltodextrin plus sucralose (combo), 3- combo with oral sweet taste receptors blocked 4- combo with extra oral sweet taste receptors blocked

Sweet taste perception with/without sweet taste blockade

Clinical Study ID

NCT06315725
2024-10504
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 Gymnemasylvestre

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: 1- maltodextrin, 2- maltodextrin plus sucralose (combo), 3- combo with oral sweet taste receptors blocked 4- combo with extra oral sweet taste receptors blocked
Phase:
Study Start date:
November 12, 2024
Estimated Completion Date:
December 01, 2027

Connect with a study center

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

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

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