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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02573753
Enrollment
5000
Registered
2015-10-12
Start date
2015-10-01
Completion date
2031-12-01
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

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.

Interventions

BEHAVIORALSleep restriction
DIETARY_SUPPLEMENTWeight gain

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Crossover; Single group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in human microbiota induced by sleep manipulation in healthy subjects1 year
Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects20 weeks

Countries

United States

Contacts

CONTACTNick Wozniak
Wozniak.Nicholas@mayo.edu507-255-8794
CONTACTLaura Hammel
Hammel.Laura@mayo.edu507-255-6676
PRINCIPAL_INVESTIGATORVirend Somers, MD, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026