Recruiting

Artificial Sweetener

Sponsor:

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

Code:

NCT06315725

Conditions

Type 1 Diabetes (T1D)

Healthy Subjects

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Sweet taste perception with/without sweet taste blockade

Study Details

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.

Conditions

Type 1 Diabetes (T1D)

Healthy Subjects

Study ID

NCT06315725

Start date

Nov 12, 2024

Status verified date

Nov, 2024

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Interventions

Sweet taste perception with/without sweet taste blockade

In our study, we will use our four different novel flavored beverages, with and without a sweet taste blockade.

Primary outcome measure

  • Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals [ Time Frame: 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. [ Time Frame: From enrollment to the end of treatment at 4 weeks ]

Central Contacts and Locations

Central contacts

Golnaz Arjmand, PhD

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

Locations

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

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Golnaz Arjmand, Postdoctoral Researcher

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

More Information

Sponsor

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

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

  • Type 1 Diabetes
  • Artificial Pancreas
  • Artificial Sweeteners
  • Non-Nutritive Sweeteners
  • Cross-Over
  • Taste Perception
  • Indirect Calorimetry
  • Insulin
  • Glucose Metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-11-22.