Gut MicrobiotaNCT03203044
Impact of Soylent Consumption on Human Microbiome Composition
A study testing Soylent and water diet in people with Gut Microbiota, run by University of California, Berkeley.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- Soylent and water diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2016to 16 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject population will consist of undergraduate UC Berkeley students.
Who cannot join
- 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.
About this study
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.
Read the 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."
- Conditions
- Gut Microbiota
- Being tested
- Soylent and water diet
- Keywords
- Dietary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soylent and water dietOther
A diet of five servings of Soylent 2.0 liquid meal-replacement drink per day and water as needed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Soylent and water diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to gut microbiome composition as a result of an interventional Soylent diet
Measured: Days 3-6 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start10 Oct 2016
- Primary completion16 Nov 2016
- Study completion16 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam P. Arkin, University of California, Berkeley
- Investigators
- Adam P Arkin, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203044
- Sponsor's protocol ID
- soylentmicrobiomeproject
- Status last verified
- Jun 2017
- First submitted
- 27 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Bacterial DNA sequencing data from collected fecal samples will be shared in a public repository. Sample labels will be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Soylent Consumption on Human Microbiome Composition
- ClinicalTrials.gov ID
- NCT03203044
- Acronym / sponsor ID
- soylentmicrobiomeproject
- Conditions
- Gut Microbiota
- Keywords
- Dietary Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Regular Diet Arm | No intervention | –Maintains a regular diet for the duration of the study. |
| Soylent Diet Arm | Experimental | Other: Soylent and water dietReceives a Soylent dietary intervention on days 3-6 of the study. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The subject population will consist of undergraduate UC Berkeley students.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soylent and water dietA diet of five servings of Soylent 2.0 liquid meal-replacement drink per day and water as needed. | Other | Soylent Diet Arm |
Primary outcome
Changes to gut microbiome composition as a result of an interventional Soylent diet
Time frame: Days 3-6 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Individual participant dataSharing planned: Yes. Bacterial DNA sequencing data from collected fecal samples will be shared in a public repository. Sample labels will be deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam P Arkin, PhD principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A study testing Soylent and water diet in people with Gut Microbiota, run by University of California, Berkeley.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to gut microbiome composition as a result of an interventional Soylent diet (time frame: Days 3-6 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.