To determine the effects of Artificial sweeteners & Nutritive sweetener on the gut microbiota and its influence on the length of telomere in the adult diabetic population: Open-Labelled Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Artificial sweeteners, may alter the Gut Microbiota.
研究概览
简要总结
This is an open-labelled prospective randomized controlled trial with a Control group as non-diabetic population. Participants in the intervention group will be randomly assigned to one of the three arms – Arm 1 will receive Sucralose, Arm 2 will receive Stevia, and Arm 3 will receive brown sugar. The participants in the intervention group will consume the assigned sweetener for 28 weeks, whereas the participants in the control group will continue their usual diet. The participant’s gut microbiota and telomere length will be measured at baseline, after 2 weeks, and after 26 weeks. The study will involve collecting stool samples and blood samples from the participants. The stool samples will be used to analyze the gut microbiota, and the blood samples will be used to measure telomere length.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligible participants (age >18 years) with type 2 diabetes The participants who accept to adhere to the dietary plan and avoid consuming other sources of artificial sweeteners will be considered.
排除标准
- •Patients with Type 1 Diabetes Patients with Gestational Diabetes Mellitus Patients with an History of non-tolerance to artificial sweeteners Patients who consumed any artificial sweeteners prior to the study in the last 1 month Patients with malignancy, or had undergone chemo radio therapy.
结局指标
主要结局
Artificial sweeteners, may alter the Gut Microbiota.
时间窗: 0 to 8 months
次要结局
- Artificial sweeteners may modulate the length of telomere(0 to 8 months)