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The Metabolic and Circadian Effects of Shift Work

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05177965
Acronym
OPTI-SHIFT
Enrollment
72
Registered
2022-01-05
Start date
2022-02-01
Completion date
2024-08-30
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shift Work Schedule

Brief summary

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.

Interventions

OTHERExposure to shift work

Detailed questionnaire adapted from the Standard Shiftwork Index, measured at inclusion

Sponsors

Tinh-Hai Collet, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in glucose excursionBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by Continuous Glucose Monitoring

Secondary

MeasureTime frameDescription
Difference in nutrient intakeBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsTotal calorie and macronutrient intake over a 24-hour period
Difference in sleep qualityBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by the Pittsburgh Sleep Quality Index (PSQI), score ranges from 0 to 21 points, 0 indicating no difficulty and 21 severe difficulties
Difference in attention and sleepinessBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by the Sustained Attention to Response Test
Difference in well-beingBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by the World Health Organization-5 questionnaire (WHO-5), score ranges from 0 to 25, 0 indicating worst possible and 25 best possible
Difference in mental health outcomesBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by the Patient Health Questionnaire-9 (PHQ-9), score ranges from 0 to 27, 0 indicating no depression and 27 severe depression
Difference in fasting glucoseBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by clinical chemistry (mmol/L)
Difference in weightBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsBody weight (Kg)
Difference in waist circumferenceBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsWaist circumference (cm) assessed with a measuring tape
Difference in lipid profileBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsTotal cholesterol, triglycerides, HDL cholesterol, LDL cholesterol measured by clinical chemistry (mmol/L)
Difference in blood hormonal profileBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsInsulin (mIU/L), thyroid-stimulating hormone (mIU/L), cortisol (nmol/L) measured by clinical chemistry
Difference in eating durationBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsTime from the first to last caloric intake over a 24-hour period
Difference in systolic and diastolic blood pressureBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by blood pressure arm cuff
Difference in heart rate variabilityBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by wearable sensor
Difference in physical activityBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by actigraphy and the International Physical Activity Questionnaire
Difference in sleep/wake cyclesBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by actigraphy

Other

MeasureTime frameDescription
Difference in the exposure to ambient lightBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by wearable spectrometer and the light exposure behaviour assessment (LEBA) questionnaire
Difference in the core body temperatureBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by a wearable skin temperature and heat transfer sensor
Difference in blood metabolomic parametersBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by high-throughput mass spectrometry metabolomics, semi-quantitative identification of small metabolites involved in carbohydrate, fat, protein, and steroid metabolism
Difference in lipid metabolismBetween a series of day shifts and a series night shifts, separated by an interval from 10 days to 3 monthsAs measured by high-throughput mass spectrometry lipidomics

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026