The Effects of Sleep on Human Microbiota: Implications for Health and Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleep restriction, Weight gain.
- Who it may be relevant to
- Registry conditions: Sleep. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Sleep restriction
- Dietary supplement Weight gain
Primary outcome measures
- Changes in human microbiota induced by sleep manipulation in healthy subjects [Time frame: 1 year]
- Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects [Time frame: 20 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Mayo Clinic Rochester — Rochester
Identifiers
NCT: NCT02573753 · 15-002092