SleepNCT02573753
The Effects of Sleep on Human Microbiota: Implications for Health and Disease
A study testing Sleep restriction and Weight gain in people with Sleep, run by Mayo Clinic at 1 site in United States.
Trial summary
The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep restriction and Weight gain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.
Who cannot join
- Pregnant or breast-feeding women
- Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Nick Wozniak, 507-255-8794, Wozniak.Nicholas@mayo.edu
Laura Hammel, 507-255-6676, Hammel.Laura@mayo.edu
About this study
The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease; and thereby, could be used to predict disease onset and additionally monitor response to treatment and predict prognosis. The primary hypothesis of this pilot study is that the human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns, and they may ultimately relate to disease risk.
- Conditions
- Sleep
- Being tested
- Sleep restriction, Weight gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionBehavioural
Weight gainDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| sleep restriction | Experimental | Sleep restriction Receives: Behavioral: Sleep restriction |
| normal sleep | No intervention | Normal sleep |
| weight gain | Experimental | Weight gain Receives: Dietary Supplement: Weight gain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in human microbiota induced by sleep manipulation in healthy subjects
Measured: 1 year
Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover; Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573753
- Sponsor's protocol ID
- 15-002092
- Status last verified
- Jul 2026
- First submitted
- 7 Oct 2015
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sleep on Human Microbiota: Implications for Health and Disease
- ClinicalTrials.gov ID
- NCT02573753
- Acronym / sponsor ID
- 15-002092
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- 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.
The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease; and thereby, could be used to predict disease onset and additionally monitor response to treatment and predict prognosis. The primary hypothesis of this pilot study is that the human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns, and they may ultimately relate to disease risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover; Single group
| Arm | Type | Receives |
|---|---|---|
| sleep restriction | Experimental | Behavioral: Sleep restrictionSleep restriction |
| normal sleep | No intervention | –Normal sleep |
| weight gain | Experimental | Dietary Supplement: Weight gainWeight gain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women
- Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol
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 |
|---|---|---|
| Sleep restriction | Behavioural | sleep restriction |
| Weight gain | Dietary supplement | weight gain |
Primary outcome
Changes in human microbiota induced by sleep manipulation in healthy subjects
Time frame: 1 year
Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Virend Somers, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep restriction and Weight gain in people with Sleep, run by Mayo Clinic at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nick Wozniak (507-255-8794, Wozniak.Nicholas@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in human microbiota induced by sleep manipulation in healthy subjects (time frame: 1 year). The study lists 2 primary outcomes in all. 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 4 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.