Impact of Soylent Consumption on Human Microbiome Composition
Condition: Gut Microbiota
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      All electronic logs and samples will be labeled with each participant's unique participant
      ID. The link between each participant and their sample kits will be maintained on the
      participant reference sheet kept by the researchers. uBiome will not have access to this
      link.

      Once all data in the study has been received, the participant reference sheet will be
      shredded and all of the data will become unidentifiable. While Soylent has no documented
      instances of causing physical complications to consumers, if any participant feels unwell
      during any point in the study, they are encouraged to cease participation and contact their
      primary care doctor for guidance.

      Results from the uBiome gut kits will be received in about four to six weeks. uBiome will
      share the data individually with each participant (if participants chose to create an account
      and register their kits as stated above) and in bulk with the researchers. For participants
      that did not register their kits with uBiome, the data generated from those participants will
      only be sent to the researchers. The data consists of sequencing data labeled with each kit's
      serial number. We will then correlate our electronic log data with the uBiome sample data for
      further analysis. The data generated in this study is in no way intended for medical
      diagnosis of any kind. uBiome's website states the following: "It's important to be aware
      that uBiome is designed to be a tool for personal research, NOT a diagnostic tool. You won't
      find any predictions about your future health. And your results will not diagnose any medical
      condition."
    

Intervention name(s): Soylent and water diet
Intervention type(s): Other
Intervention description(s): A diet of five servings of Soylent 2.0 liquid meal-replacement drink per day and water as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are separated into two diet arms. The regular diet arm remains on a self-reported regular diet for the duration of the study. The Soylent diet arm maintains a regular diet for two days, switches to an all Soylent and water diet for four days, and returns to a regular diet for four days.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dietary Intervention