NCT03203044

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

1 month

First QC Date

June 27, 2017

Last Update Submit

June 27, 2017

Conditions

Keywords

Dietary Intervention

Outcome Measures

Primary Outcomes (1)

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

    Days 3-6 of the study

Study Arms (2)

Regular Diet Arm

NO INTERVENTION

Maintains a regular diet for the duration of the study.

Soylent Diet Arm

EXPERIMENTAL

Receives a Soylent dietary intervention on days 3-6 of the study.

Other: Soylent and water diet

Interventions

A diet of five servings of Soylent 2.0 liquid meal-replacement drink per day and water as needed.

Soylent Diet Arm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Adam P Arkin, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 27, 2017

First Posted

June 29, 2017

Study Start

October 10, 2016

Primary Completion

November 16, 2016

Study Completion

November 16, 2016

Last Updated

June 29, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Bacterial DNA sequencing data from collected fecal samples will be shared in a public repository. Sample labels will be deidentified.