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

NCT02573753 | Recruiting

• 1 other identifier: 15-002092
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Changes in human microbiota induced by sleep manipulation in healthy subjects

  1 year

• Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects

  20 weeks

Study Arms (3)

sleep restriction

EXPERIMENTAL

Sleep restriction

Behavioral: Sleep restriction

normal sleep

NO INTERVENTION

Normal sleep

weight gain

EXPERIMENTAL

Weight gain

Dietary Supplement: Weight gain

Interventions

Sleep restriction BEHAVIORAL

sleep restriction

Weight gain DIETARY_SUPPLEMENT

weight gain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Virend Somers, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nick Wozniak

CONTACT

507-255-8794; Wozniak.Nicholas@mayo.edu

Laura Hammel

CONTACT

507-255-6676; Hammel.Laura@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Model Details: Crossover; Single group

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 12, 2015
• Study Start: October 1, 2015
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)