Sleep Restriction's Impact on Microbiota and Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Sleep Restriction Therapy on gut microbiota and health?

Research shows that sleep restriction can reduce the richness of gut microbiota, but it doesn't significantly change the overall composition or intestinal health in humans. This suggests that while sleep restriction affects gut bacteria diversity, it may not have a major impact on gut health. ^{1 2 3 4 5}

Is sleep restriction generally safe for humans?

Research shows that short-term sleep restriction can reduce the variety of gut bacteria in healthy young men but does not significantly change the overall gut bacteria composition or affect gut barrier function. In humans, the gut microbiome seems largely resistant to changes during sleep restriction, suggesting it is generally safe in the short term. ^{2 4 5 6 7}

How does sleep restriction treatment differ from other treatments for gut microbiota and health?

Sleep restriction treatment is unique because it focuses on altering sleep patterns to study their impact on gut microbiota and health, rather than using medications or supplements. Unlike other treatments that might directly target the gut microbiome, sleep restriction examines how changes in sleep duration and quality can indirectly affect the microbiome and related health outcomes. ^{1 2 4 5 6}

Research Team

Virend Somers, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals who are part of ongoing IRB-approved studies, focusing on how sleep affects the body's microorganisms. Pregnant or breastfeeding women are not eligible to participate.

Inclusion Criteria

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

Exclusion Criteria

Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol.

Pregnant or breast-feeding women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sleep Restriction

Participants undergo sleep restriction to study its effects on human microbiota

4 weeks

Normal Sleep

Participants maintain normal sleep patterns to serve as a control group

4 weeks

Weight Gain

Participants experience weight gain to study its effects on human microbiota

4 weeks

Follow-up

Participants are monitored for changes in microbiota and health outcomes after interventions

4 weeks

Treatment Details

Interventions

• Sleep restriction
• Weight gain

Trial Overview The study examines if and how sleep patterns influence human microbiota, which could potentially affect health and predict diseases. It involves observing weight changes and imposing sleep restrictions on participants.

Participant Groups

Group I: weight gain Experimental Treatment 1 Intervention

Weight gain

Group II: sleep restriction Experimental Treatment 1 Intervention

Sleep restriction

Group III: normal sleep Active Control 1 Intervention

Normal sleep

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. France pubmed.ncbi.nlm.nih.gov

Melatonin improves the homeostasis of mice gut microbiota rhythm caused by sleep restriction. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Severe, short-term sleep restriction reduces gut microbiota community richness but does not alter intestinal permeability in healthy young men. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Differential Effect of Light and Dark Period Sleep Fragmentation on Composition of Gut Microbiome and Inflammation in Mice. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Human and rat gut microbiome composition is maintained following sleep restriction. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Acute Sleep-Wake Cycle Shift Results in Community Alteration of Human Gut Microbiome. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Sleep and Circadian Disruption and the Gut Microbiome-Possible Links to Dysregulated Metabolism. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Effects of a calorie-restricted dietary intervention on weight loss and gut microbiota diversity in obese patients with sleep deprivation. [2023]