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NCT02573753 Clinical Trial

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

Sleep Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02573753
Other study ID # 15-002092
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date June 2027

Study information
Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 5000
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Sleep restriction

Dietary Supplement:
• Weight gain

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in human microbiota induced by sleep manipulation in healthy subjects 1 year
Primary Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects 20 weeks
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