A Randomized Cross-Over Study to Investigate the Effect of the Non-Nutritive Sweetener Sucralose on Glucose Metabolism in Patients with Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals
时间窗: from enrollment to the end of treatment at 4 weeks
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.
Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption.
时间窗: From enrollment to the end of treatment at 4 weeks
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
次要结局
- Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption(from enrollment to the end of treatment at 4 weeks)
研究者
Dana Small
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre