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Microbiome Assessment for Shift Workers

N/A
Waitlist Available
Led By Carsten Skarke, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Volunteers capable of giving informed consent
40-59 years of age
Must not have
History of abdominal surgery
Planned travel across more than two time zones during the planned study activities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of night shift work on the microbiome, and how this may contribute to disease risk.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves consuming a standardized meal and undergoing a glucose challenge test rather than testing new medications, side effects are minimal but may include discomfort from blood draws or potential reactions to the meal components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to understand and agree to the study's procedures and risks.
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I am between 40 and 59 years old.
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I am a male and I do not smoke.
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I am a healthy man, aged 40-59, working shifts outside 7am-6pm for over 10 years without medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery in my abdomen before.
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I plan to travel across more than two time zones during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the glucose over time curve
Secondary study objectives
Heart rate
Compound outcome derived from variance observed in multiomics outputs (metabolites, microbiota).
Time-of-day dependent fluctuations of the microbiome

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Matched healthy controls receive a standardized meal with a glucose challenge test
Group II: Cohort 1Experimental Treatment1 Intervention
Shift workers receive a standardized meal with a glucose challenge test

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,521 Total Patients Enrolled
Carsten Skarke, MDPrincipal InvestigatorUniversity of Pennsylvania
7 Previous Clinical Trials
240 Total Patients Enrolled

Media Library

Standardized meal with a glucose challenge test Clinical Trial Eligibility Overview. Trial Name: NCT03221517 — N/A
Healthy Subjects Research Study Groups: Cohort 2, Cohort 1
Healthy Subjects Clinical Trial 2023: Standardized meal with a glucose challenge test Highlights & Side Effects. Trial Name: NCT03221517 — N/A
Standardized meal with a glucose challenge test 2023 Treatment Timeline for Medical Study. Trial Name: NCT03221517 — N/A
~2 spots leftby Nov 2026
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