Microbiome Assessment for Shift Workers

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Anticholinergics, Laxatives, Anti-diarrhea, others

Disqualifiers: Illicit drugs, Abdominal surgery, others

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

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to be un-medicated, so you will need to stop taking any current medications before joining. Additionally, you must avoid certain vitamins, alcohol, NSAIDs (a type of pain reliever), anticholinergics (medications that block certain nerve impulses), laxatives, and anti-diarrhea medications for specific periods before certain study activities.

What data supports the effectiveness of the treatment Standardized meal with a glucose challenge test for shift workers?

Research shows that disruptions in circadian rhythms, like those experienced by shift workers, can affect gut health and metabolism. While the specific treatment of a standardized meal with a glucose challenge test isn't directly studied, understanding gut microbiota changes and their link to metabolic health in shift workers suggests that dietary interventions could help manage these effects. ^{1 2 3 4 5}

How does the treatment for shift workers' microbiome differ from other treatments?

This treatment is unique because it focuses on assessing and potentially modifying the gut microbiome of shift workers, which is affected by circadian rhythm disruptions. Unlike standard treatments for metabolic disorders, this approach targets the gut microbiota, which may play a role in the health issues associated with shift work. ^{2 3 5 6 7}

What is the purpose of this trial?

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.

Research Team

Carsten Skarke, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for non-smoking men aged 40-59 who have been working night shifts or regular day shifts for over 10 years. Participants should be healthy, not on medication, and own an Android smartphone. They can't join if they've traveled across time zones recently, had abdominal surgery, used certain drugs or supplements recently, or have any health issues that could affect the study.

Inclusion Criteria

I am a healthy man, aged 40-59, working shifts outside 7am-6pm for over 10 years without medication.

I am able to understand and agree to the study's procedures and risks.

Own an android smartphone which installs the remote sensing applications (those with apple smartphones will not be recruited)

Exclusion Criteria

I haven't taken high dose vitamins, alcohol, or NSAIDs in the last two weeks.

High fat foods and caffeine in the past 24 hours prior to the 48-hour deep chronotyping session

Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including core body temperature, sleep/activity cycles, cortisol and melatonin levels, and postprandial glucose and insulin levels

1 week

Multiple assessments (in-person and remote)

Experimental Phase

Participants receive a standardized meal with a glucose challenge test and are monitored for microbiome fluctuations and other physiological outputs

48 hours

Continuous monitoring (remote)

Follow-up

Participants are monitored for safety and effectiveness after the experimental phase

4 weeks

Treatment Details

Interventions

• Standardized meal with a glucose challenge test

Trial Overview The study aims to understand how working night shifts affects the microbiome compared to regular day shift workers by examining their behavior, clinical data, and metabolites after eating a standardized meal followed by a glucose test.

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

Matched healthy controls receive a standardized meal with a glucose challenge test

Group II: Cohort 1 Experimental Treatment 1 Intervention

Shift workers receive a standardized meal with a glucose challenge test

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

References

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

Effects of sleeve gastrectomy on the composition and diurnal oscillation of gut microbiota related to the metabolic improvements. [2018]

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

Changes in intestinal parameters and their association with dietary patterns in rotational shift workers. [2022]

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

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

4. England pubmed.ncbi.nlm.nih.gov

The intestinal clock drives the microbiome to maintain gastrointestinal homeostasis. [2022]

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

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

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

The circadian disruption of night work alters gut microbiota consistent with elevated risk for future metabolic and gastrointestinal pathology. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Habitual Sleep Duration and the Colonic Mucosa-Associated Gut Microbiota in Humans-A Pilot Study. [2021]