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临床试验/NCT04633369
NCT04633369进行中(未招募)不适用

The Role of the Microbiome and Host Physiology in Personalized Human Response to Dietary Fibers Intake During Intermediate Fasting

Weizmann Institute of Science1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2021年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
115
试验地点
1
主要终点
glycemic response of different dietary fibers

研究概览

简要总结

Dietary fibers are generally not degraded by the endogenous digestive enzymes, but rather by the complex ensemble of microorganisms that reside in the human gut [1]. This ensemble, collectively known as the human gut microbiome, plays a key role in breaking down, fermenting, and ultimately converting such dietary fibers into a variety of beneficial metabolites, including most notably, short chain fatty acids (SCFA). These end products of fibers' fermentation affect host metabolism, immunity, and physiology, and have been implicated in multiple diseases including obesity, metabolic syndrome, diabetes, and cardiovascular diseases.

Intermediate fasting, and in particular circadian intermediate fasting (i.e. 16 hours of fasting followed by 8 hours of allowed eating), has been shown to have positive associations with multiple health conditions as obesity, diabetes mellitus, cardiovascular disease, cancers, and neurologic disorders In this study, we will try to answer open questions utilizing the long fasting period during the day to investigate the isolated effect of dietary fiber consumption, uncovering the degradation effect, but not the bulking effect, on the microbiome and the host physiology, and in particular its glucose response.

详细描述

During the 22 days of the study, participants will wear a continuous glucose monitor, fill a daily food diary, and collect stool and oral samples which will be used for microbiota profiling. Participants will be asked to carry out an intermediate fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. Drinking water is allowed throughout the fasting hours.

The groups will consume 4, 12, 20 grams of the dietary fiber per day, according to the group they were assigned to, while not exceeding the total fiber consumption of 50 grams per day, which is considered a high-fiber diet.

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
Single (Participant)

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

  • Male and Female BMI<28 Age - 18-70

排除标准

  • Consumption of antibiotics 3 months prior to the first day of the experiment. Consumption of probiotic or dietary fibers supplements 1 month prior to the first day of the experiment.
  • Practiced in intermediate fasting 1 month prior to the first day of the experiment.
  • Diagnosis with type 1 or type 2 diabetes. Pregnancy, breastfeeding, or fertility treatments in the last 6 months. Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism hepatitis, fibromyalgia, etc.).
  • Cancer and recent anticancer treatment. Psychiatric disorders. Coagulation disorders. IBD (inflammatory bowel diseases). IBS (Irritable bowel syndrome). Alcohol abuse, more than 2 drinks per day for males, and more than one drink for females.
  • Substance abuse. BMI>
  • Daily dietary intake higher than 25 grams per day. History of abdominal surgeries (including Bariatric surgery). Mentally incompetent or lack of judgment

结局指标

主要结局

glycemic response of different dietary fibers

时间窗: 1 year

Continuous glucose monitoring (CGM)

microbiome

时间窗: 1 year

stool and oral samples

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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