The Effects of Sleep on Human Microbiota: Implications for Health and Disease

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT02573753
Status
Recruiting
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Conditions

  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sleep restriction — BEHAVIORAL
  • Weight gain — DIETARY_SUPPLEMENT

Study Details

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.

Key Dates

Start date
Oct 31, 2015
Status verified
Jul 2025
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
5,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: sleep restriction
    Sleep restriction
  • No Intervention: normal sleep
    Normal sleep
  • Experimental: weight gain
    Weight gain

Primary Outcome Measure

Changes in human microbiota induced by sleep manipulation in healthy subjects [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic RochesterRochesterMinnesota55905
Nick Wozniak
[email protected]
507-255-8794
Laura Hammel
[email protected]
507-255-6676
Virend Somers, MD, PhD (PRINCIPAL_INVESTIGATOR)

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