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

Mayo Clinic

Status: Enrolling

Conditions: Sleep

Treatments: Behavioral: Sleep restriction; Dietary Supplement: Weight gain

Study type: Interventional

Funder types: Other

Identifiers

NCT02573753

15-002092

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5,000 participants in 3 patient groups

sleep restriction

Experimental group

Description:

Sleep restriction

Treatment:

Behavioral: Sleep restriction

normal sleep

No Intervention group

Description:

Normal sleep

weight gain

Experimental group

Description:

Weight gain

Treatment:

Dietary Supplement: Weight gain