Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D) (AFS_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
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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Quebec
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Montreal、Quebec、加拿大、H4A 3J1
- Center for Innovative Medicine, The Research Institute of the McGill University Health Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
For the pilot study, 10 healthy participants will be recruited. For the main study, 15 potential participants with T1D will be recruited.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CROSSOVER
- 时间观点：OTHER
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals
大体时间：from enrollment to the end of treatment at 4 weeks
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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
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Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption.
大体时间：From enrollment to the end of treatment at 4 weeks
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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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption
大体时间：from enrollment to the end of treatment at 4 weeks
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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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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