The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Blood glucose level
研究概览
简要总结
Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. While they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. The investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. The proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age - 18-70
- •Capable of working with smartphone application
- •Capable to work with a glucometer
排除标准
- •Consumption of antibitioics 3 months prior to the first day of the experiment.
- •Consumption of Non caloric sweetners 6 months prior to the first day of the experiment.
- •Diagnosis with type 1 or type 2 diabetes.
- •Pregnancy, fertility treatments
- •Breastfeeding (Including baby to breast and bottle feeding expressed breast milk)
- •Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
- •Cancer and recent anticancer treatment
- •Psychiatric disorders
- •Coagulation disorders
- •IBD (inflammatory bowel diseases)
- •Bariatric surgery
- •Alcohol or substance abuse
- •Aspartame group only: phenylketonuria.
结局指标
主要结局
Blood glucose level
时间窗: 28 days
Continuous glucose monitor device
次要结局
- Microbiome(28 days)
研究者
Eran Elinav
Prof. Eran Elinav
Weizmann Institute of Science
