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

Healthy Subjects Clinical Trial

— AFS_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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315725
• Other study ID #: 2024-10504
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: April 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Golnaz Arjmand, PhD
• Phone: 514-398-3020
• Email: golnaz.arjmand[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Healthy Subjects
• Type 1 Diabetes (T1D)

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals	our aim is to test whether the impact of consuming NNS with carbohydrates on glucose metabolism is related to oral or post-oral sweet taste receptor signaling.	from enrollment to the end of treatment at 4 weeks
Primary	Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption.	Consuming NNS alongside carbohydrates affects glucose metabolism differently compared to carbohydrates alone in participants with type 1 diabetes (T1D) using an artificial pancreas (AP) system for exogenous insulin production	From enrollment to the end of treatment at 4 weeks
Secondary	Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption	To test whether the co-ingestion of the NNS with carbohydrate can result in changes in post-ingestion metabolism, we plan to employ indirect calorimetry (IC) to evaluate resting energy expenditure (REE) before and after flavoured beverages consumption.	from enrollment to the end of treatment at 4 weeks