Clinical trial NCT06315725: Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients with Type 1 Diabetes (T1D)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes (T1D)
Healthy Subjects
Keywords: Type 1 Diabetes
Artificial Pancreas
Artificial Sweeteners
Non-Nutritive Sweeteners
Cross-Over
Taste Perception
Indirect Calorimetry
Insulin
Glucose Metabolism
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: For the pilot study, 10 healthy participants will be recruited. For the main study, 15 potential participants with T1D will be recruited.

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.


Eligibility 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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption
timeFrame: from enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Center for Innovative Medicine, The Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
References: