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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Quebec
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Montreal、Quebec、カナダ、H4A 3J1
- Center for Innovative Medicine, The Research Institute of the McGill University Health Centre
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
For the pilot study, 10 healthy participants will be recruited. For the main study, 15 potential participants with T1D will be recruited.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_CROSSOVER
- 時間の展望：OTHER
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals
時間枠：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.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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