The Metabolic and Circadian Effects of Shift Work (OPTI-SHIFT)

November 14, 2025 updated by: Tinh-Hai Collet, MD

The Metabolic and Circadian Effects of Shift Work - An Observational Study

In an exploratory observational pilot study, the investigators will focus on the effects of short-term circadian misalignment induced by shift work on multidimensional measurements including glucose excursion, metabolic health, circadian rhythms (measured in vitro and in vivo), sleep/wake cycles and ambient light, eating and activity patterns, well-being and attention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Geneva, Switzerland, 1211
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Shift workers

Description

Inclusion Criteria:

  • Men and women
  • Age 20-50 years
  • Working ≥ 80% full-time equivalent over the previous month and during the study
  • Working night shifts (i.e. shifts that comprise working hours between 23h and 06h) in rotation with day shifts (i.e. shifts that comprise working hours between 06h and 20h)
  • Planned to work at least 3 consecutive night shifts during the study preceded by at least a day off or day shift
  • Planned to work at least 3 consecutive day shifts during the study
  • Confident use of a smartphone compatible with the study application (iOS, Android) and able to regularly take pictures of consumed food/drinks
  • Able to give a fully informed consent and follow the study procedures

Exclusion Criteria:

  • Planned or current pregnancy during the study
  • Menopausal women
  • Major illness or hospitalization over the previous month
  • Carries a pacemaker, pump or other medical device that can be disabled by a magnet
  • Major mental illness
  • Trip to a different time zone (≥ 2-hour time difference) over the previous month or planned during the study
  • Enrolled in an interventional clinical trial (potentially interfering with the main outcomes) over the previous month or planned during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Shift workers
Measurements repeated during a series of day shifts and during a series of night shifts
Detailed questionnaire adapted from the Standard Shiftwork Index, measured at inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in glucose excursion
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by Continuous Glucose Monitoring
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in fasting glucose
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by clinical chemistry (mmol/L)
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in weight
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Body weight (Kg)
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in waist circumference
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Waist circumference (cm) assessed with a measuring tape
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in lipid profile
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol measured by clinical chemistry (mmol/L)
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in blood hormonal profile
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Insulin (mIU/L), thyroid-stimulating hormone (mIU/L), cortisol (nmol/L) measured by clinical chemistry
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in eating duration
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Time from the first to last caloric intake over a 24-hour period
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in nutrient intake
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Total calorie and macronutrient intake over a 24-hour period
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in systolic and diastolic blood pressure
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by blood pressure arm cuff
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in heart rate variability
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by wearable sensor
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in physical activity
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by actigraphy and the International Physical Activity Questionnaire
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in sleep/wake cycles
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by actigraphy
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in sleep quality
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by the Pittsburgh Sleep Quality Index (PSQI), score ranges from 0 to 21 points, 0 indicating no difficulty and 21 severe difficulties
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in attention and sleepiness
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by the Sustained Attention to Response Test
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in well-being
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by the World Health Organization-5 questionnaire (WHO-5), score ranges from 0 to 25, 0 indicating worst possible and 25 best possible
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in mental health outcomes
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by the Patient Health Questionnaire-9 (PHQ-9), score ranges from 0 to 27, 0 indicating no depression and 27 severe depression
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in blood metabolomic parameters
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by high-throughput mass spectrometry metabolomics, semi-quantitative identification of small metabolites involved in carbohydrate, fat, protein, and steroid metabolism
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in lipid metabolism
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by high-throughput mass spectrometry lipidomics
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in the exposure to ambient light
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by wearable spectrometer and the light exposure behaviour assessment (LEBA) questionnaire
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
Difference in the core body temperature
Time Frame: Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months
As measured by a wearable skin temperature and heat transfer sensor
Between a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tinh-Hai Collet, MD, Geneva University Hospitals, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-01088

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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