Mapping the Shift Worker's Microbiome

NCT03221517 | Active Not Recruiting

• 1 other identifier: 826117
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the glucose over time curve

  Area under the curve (AUC) will be calculated from serial, timed glucose measurements

  12 hour

Secondary Outcomes (3)

• Time-of-day dependent fluctuations of the microbiome

  48 hours

• Compound outcome derived from percent variance explained in communication (number of phone calls and text messages), mobility (miles traveled), light exposure, blood pressure, heart rate, heart rate variability, sleep/wake times, body core temperature

  48 hours

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

  48 hours

Study Arms (2)

Cohort 1

EXPERIMENTAL

Shift workers receive a standardized meal with a glucose challenge test

Other: Standardized meal with a glucose challenge test

Cohort 2

EXPERIMENTAL

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

Other: Standardized meal with a glucose challenge test

Interventions

Standardized meal with a glucose challenge test OTHER

Postprandial glucose and insulin response

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cohort 1: healthy un-medicated males (to limit gender-induced variability similar to our pilot study), shift-work schedule (\>3 shifts per month outside 7am-6pm (9)) for the past ≥10 years, 40-59 years old (increased prevalence of the metabolic syndrome at ≥60 years of age (20));
• Cohort 2: day workers who work 7am-6pm for ≥10 years matched for line of work, age, gender, and BMI;
• Volunteers are capable of giving informed consent;
• years of age;
• Own an android smartphone which installs the remote sensing applications (those with apple smartphones will not be recruited);
• Non-smoking;
• Male subjects
• The use of contraception will NOT be required for male participants.

You may not qualify if:

• Recent travel across more than two (2) time zones (within the past month);
• Planned travel across more than two (2) time zones during the planned study activities;
• Use of illicit drugs;
• High dose vitamins (Vitamin A, Vitamin C, Vitamin E, Beta Carotene, Folic Acid and Selenium), alcohol and any over-the counter NSAID in the (2) two weeks before the start of the 48 hour deep phenotyping;
• High fat foods and caffeine in the past 24 hours prior to the 48-hour deep chronotyping session;
• History of abdominal surgery;
• Known allergy or intolerance to Vancomycin, and/or Neomycin;
• Use of anticholinergics in the week prior to the 48-hour sessions;
• Use of laxatives or anti-diarrhea medications in the two weeks prior to the 48-hour sessions;
• Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening;
• 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;

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Carsten Skarke, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: July 18, 2017
• Study Start: September 27, 2017
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)