Healthy Clinical Trial - Mapping the Shift Worker's Microbiome

Status Active, not recruiting

Clinical Trial Summary

The investigators hypothesize that disruptions to the microbiome of shift-workers represent a hitherto unexamined factor contributing to disease risk. The investigators will therefore define time-of-day dependent fluctuations of the microbiome in night shift workers and matched daytime workers deeply phenotyped for behavioral, clinical, and metabolomic outputs using integrated remote sensing.

Clinical Trial Description

Though several epidemiological studies have demonstrated that working night shift schedules are a risk factor for developing metabolic and cardiovascular diseases, the mechanisms through which this is conferred is not yet understood. Shift-work schedules alter employee's patterns of activity, light exposure and dietary intake in a manner incongruent with the endogenous clock. This circadian clock ensures that our metabolic activity occurs at maximally beneficial times of the day, but is largely unable to adapt to rapidly shifting schedules or sustained night-work. In mice, the investigators' lab has previously shown that genes relevant to all aspects of the metabolic syndrome are subject to circadian oscillation and that the gut microbiome is also subject to control by the host molecular clock. Despite the large contribution of our microbiome to host metabolism, the microbiome has been scarcely studied in the shift-working population. The investigators hypothesize that disruptions to the microbiome of shift-workers represent a hitherto unexamined factor contributing to disease risk. The investigators will therefore define time-of-day dependent fluctuations of the microbiome in night shift workers and matched daytime workers deeply phenotyped for behavioral, clinical, and metabolomic outputs using integrated remote sensing. The investigators will assess core body temperature, sleep/activity cycles, cortisol and melatonin as outputs determined by the host clock, and postprandial glucose and insulin levels as well as nocturnal blood pressure dipping as risk-related outputs. Through antibiotic-induced suppression, The investigators will determine the microbiome's specific contribution to these outputs. This has major implications for refining shift-work schedules and exploring therapeutic strategies in this population. ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT03221517
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 27, 2017
Completion date	July 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.