Microbiome Assessment for Shift Workers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how shift work affects the gut microbiome and potentially influences disease risk. Researchers will provide both shift workers and regular day workers with a standardized meal and a glucose challenge test to observe microbiome changes at different times of the day. Healthy males who have been shift workers for over 10 years or consistent day workers with similar job roles may be a good fit. Participants need an Android smartphone for the study's remote sensing applications.
As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could improve health outcomes for shift workers.
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 prior data suggests that the standardized meal with a glucose challenge test is safe?
Research has shown that the meal used in the glucose challenge test is generally safe for people in clinical studies. In one study, researchers used the body's response to a mixed meal to predict the risk of developing type 2 diabetes and found no serious side effects from the meal itself.
The glucose challenge test is also a common method in healthcare to assess how the body handles sugar. Most people tolerate it well, though some might experience mild and temporary discomfort, such as feeling full or having a slight stomach upset.
Overall, research suggests that both the standardized meal and the glucose challenge test are safe for use in this type of study.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to understand how a standardized meal and glucose challenge test can impact the gut microbiome of shift workers. Unlike traditional approaches that might not account for the unique metabolic stresses faced by shift workers, this study explores how their eating patterns and glucose responses differ from those of non-shift workers, or healthy controls. By comparing these two groups, researchers hope to uncover insights into how shift work affects metabolism and gut health, potentially paving the way for tailored dietary or lifestyle interventions.
What evidence suggests that this trial's treatments could be effective for assessing microbiome disruptions in shift workers?
Research shows that working night shifts can alter gut bacteria, potentially increasing health risks. Studies have found that night workers often experience changes in their gut bacteria, leading to inflammation and other health issues. In this trial, participants will receive a standardized meal with a glucose challenge test to assess how their body processes sugar after eating. Previous participants demonstrated significant variation in blood sugar levels based on personal factors. Understanding these differences might help manage health risks related to shift work.26789
Who Is on the Research Team?
Carsten Skarke, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessments including core body temperature, sleep/activity cycles, cortisol and melatonin levels, and postprandial glucose and insulin levels
Experimental Phase
Participants receive a standardized meal with a glucose challenge test and are monitored for microbiome fluctuations and other physiological outputs
Follow-up
Participants are monitored for safety and effectiveness after the experimental phase
What Are the Treatments Tested in This Trial?
Interventions
- Standardized meal with a glucose challenge test
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor