RecruitingNCT06315725

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

A Randomized Cross-Over Study to Investigate the Effect of the Non-Nutritive Sweetener Sucralose on Glucose Metabolism in Patients with Type 1 Diabetes


Sponsor

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

Enrollment

25 participants

Start Date

Nov 12, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how artificial sweeteners affect blood sugar control in people with type 1 diabetes (T1D) who use an insulin pump. Researchers want to understand whether consuming artificial sweeteners changes how glucose is processed compared to regular sugar or no sweetener. **You may be eligible if...** - You have been diagnosed with type 1 diabetes - Your most recent HbA1c (a measure of average blood sugar over 3 months) is 8% or below (well-controlled) - You use an insulin pump for diabetes management - You are an adult aged 18–45 with a BMI between 18.5 and 29.9 (normal to borderline overweight) - You are a non-smoker and can communicate in English or French - You can eat chicken and fish (used in the study meals) **You may NOT be eligible if...** - You have any major medical condition other than type 1 diabetes that could affect metabolism - You have an eating disorder, alcohol or substance use disorder, or history of bariatric surgery - You have inflammatory bowel disease or a malabsorption condition - You have impaired taste or smell, are pregnant or breastfeeding, or have food allergies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSweet 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(1)

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

Montreal, Quebec, Canada

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NCT06315725


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