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Impact of Soylent Consumption on Human Microbiome Composition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203044
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Adam P. Arkin, University of California, Berkeley

Tracking Information
First Submitted Date  ICMJE June 27, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date June 29, 2017
Actual Study Start Date  ICMJE October 10, 2016
Actual Primary Completion Date November 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
Changes to gut microbiome composition as a result of an interventional Soylent diet [ Time Frame: Days 3-6 of the study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Soylent Consumption on Human Microbiome Composition
Official Title  ICMJE Impact of Soylent Consumption on Human Microbiome Composition
Brief 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."

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Gut Microbiota
Intervention  ICMJE Other: Soylent and water diet
A diet of five servings of Soylent 2.0 liquid meal-replacement drink per day and water as needed.
Study Arms  ICMJE
  • No Intervention: Regular Diet Arm
    Maintains a regular diet for the duration of the study.
  • Experimental: Soylent Diet Arm
    Receives a Soylent dietary intervention on days 3-6 of the study.
    Intervention: Other: Soylent and water diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2017)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 16, 2016
Actual Primary Completion Date November 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03203044
Other Study ID Numbers  ICMJE soylentmicrobiomeproject
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Bacterial DNA sequencing data from collected fecal samples will be shared in a public repository. Sample labels will be deidentified.
Current Responsible Party Adam P. Arkin, University of California, Berkeley
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Berkeley
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam P Arkin, PhD Professor
PRS Account University of California, Berkeley
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP