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临床试验/NCT03203044
NCT03203044已完成不适用

Impact of Soylent Consumption on Human Microbiome Composition

University of California, Berkeley0 个研究点目标入组 14 人开始时间: 2016年10月10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
14
主要终点
Changes to gut microbiome composition as a result of an interventional Soylent diet

研究概览

简要总结

Soylent 2.0 is a popular meal replacement drink that is used to supplement or replace one's regular diet. Soylent is designed to fully fulfill one's nutritional needs, but its impact on the human microbiome remains unknown. This study aims to track the composition of participants' gut microbiomes before, during, and after Soylent consumption to more holistically understand its impact on microbiome health. We predict that a short term Soylent-based diet will induce observable and reversible changes to participants' gut microbiomes.

详细描述

After collecting this preliminary information, main study participants will be chosen based on our described inclusion/exclusion criteria. We will distribute eight fecal sampling kits to each participant in preparation for the study. The study duration is 10 days and consists of three phases:

In Phase A, participants will adhere to their regular diet for two days. This initial condition provides a baseline of each participant's unique microbiome, acting as an internal control.

In Phase B, a subset of the participants, which will be chosen by random drawing from a box, will switch to an all-Soylent diet. During this phase, they will consume five bottles of Soylent 2.0 daily for four days (one for breakfast, two for lunch, and two for dinner), fully meeting a 2000kcal diet and all recommended nutritional daily values. The remaining participants will retain their regular diets for four days. These individuals act as a control for the daily variance of microbiome fluctuations.

In Phase C, participants will return to their regular diets for four days, after which the study will conclude.

For the duration of the study, participants will log their diets and bowel movements electronically on a daily basis. A printout of the Bristol Stool Chart will be provided at the beginning of the study to each participant. Each entry will be logged through a Google Form and labeled with each individual's participant ID, which will link them to their responses. The link will include name, email, and phone number. The completed forms are only accessible through a single Google account, which is password protected, encrypted, and only accessible by the investigators. In addition, participants will sample their microbiomes using the uBiome gut kits on the following days: 1, 2, 3, 4, 5, 6, 7, and 10. Sampling is done by swabbing used toilet paper after bowel movements. Participants will seal the samples in the kits and mail them to uBiome with the included prepaid postage. The investigators will not come into direct contact with any of the samples.

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 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The subject population will consist of undergraduate UC Berkeley students.

排除标准

  • Dietary allergies or sensitivities to Soylent 2.0 ingredients
  • Vulnerable individuals as defined by Committee for Protection of Human Subjects guidelines
  • Individuals with health issues
  • Individuals who take antibiotics, probiotics, alcohol, or supplements.

结局指标

主要结局

Changes to gut microbiome composition as a result of an interventional Soylent diet

时间窗: Days 3-6 of the study

次要结局

未报告次要终点

研究者

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

Adam P. Arkin

Professor

University of California, Berkeley

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