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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the glucose over time curve

Secondary outcome measures

Heart rate

Compound outcome derived from variance observed in multiomics outputs (metabolites, microbiota).

Time-of-day dependent fluctuations of the microbiome

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,076 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this clinical trial?

"This clinical trial requires the recruitment of 12 individuals who fit into a specific subset, namely day-workers aged 40 to 59 that have worked 7am - 6pm for 10+ years. Other important criteria include being non-smokers and in possession of an Android smartphone (Apple smartphones are not accepted). Male participants do not need contraception either."

Answered by AI

Is it possible to join this medical experiment at present?

"Clinicaltrials.gov indicates that this trial, first posted on September 27th 2017 and last updated December 10 2021, is not actively recruiting patients at present. Though inactive, there are 845 other ongoing studies searching for candidates to participate in their research endeavours."

Answered by AI

Could those aged 18 and up participate in this trial?

"This clinical trial is tailored for adults aged 40 to 59. Additionally, 50 studies are available for minors and 372 trials accommodate seniors over 65 years of age."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mapping the Shift Worker's Microbiome

Carsten Skarke, MD 2017. "Mapping the Shift Worker's Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03221517.

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