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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption [Срок оценки: from enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-кроссовер

Центры проведения

Канада · 1 центр

• Center for Innovative Medicine, The Research Institute of the McGill University Health Cen — Montreal

Идентификаторы

NCT: NCT06315725 · 2024-10504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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