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临床试验/NCT03708939
NCT03708939已完成不适用

The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners

Weizmann Institute of Science1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年2月19日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eran Elinav

Prof. Eran Elinav

Weizmann Institute of Science

研究点 (1)

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