Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT02573753

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sleep restriction

Weight gain

Study Details

Brief 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. 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

Study ID

NCT02573753

Start date

Oct, 2015

Status verified date

Jul, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: sleep restriction

Sleep restriction

no intervention: normal sleep

Normal sleep

experimental: weight gain

Weight gain

Interventions

Sleep restriction

Weight gain

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Virend Somers, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-04.