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RecruitingNCT06288568Shift2HealthUpdated Sep 8, 2025

Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers

An observational study in Obesity, Shift-work Disorder and Circadian Rhythm Disorders, sponsored by University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by University of Vienna · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000
Ages
21 Years and older
Sex
All
01

Study summary

Shift work is a well-known risk factor for the development of overweight and obesity, which may lead to downstream effects such as increased risk of cardiometabolic diseases and cancer. However, the biological and behavioral mechanisms underlying the obesogenicity of night shift work are not well understood. Population-based mechanistic studies in real life shift workers are needed to address how night shift work impacts metabolic health.

The investigators aim to characterize the behavioural, environmental, and biological mechanisms and pathways for the association of night shift work and obesity across Europe.

The investigators will conduct a cross sectional study in 5 European countries (Austria, Denmark, Germany, Netherlands and Poland) and recruit 1000 rotating night shift workers and day workers (200/country) from the health sector and different industries. Night and day workers will be age-frequency (3 age groups), gender and (where possible) working tasks matched. Participants will complete online questionnaires and report their diet habits in a mobile app. Body composition, dietary behavior and sensory preferences will be tested. Biologic specimens (blood, urine, saliva, hair and feces) will be collected at the workplace on a day where participants are working on a day shift (or a day off). In a subsample (Austria and Netherlands) shift workers will provide biological samples (spot blood, urine and saliva) both on a day shift and on a night shift. Biomarkers including hormones, cellular immunity and inflammation, parameters linked to gut health and metabolism of fat and sugar, appetite, oxidative stress, metabolomics and microbiota will be measured. The investigators hypothesize that compared to day workers, night shift workers will experience disrupted levels of pre-obesity markers. Higher circadian disruption, sleep disruption and mistimed eating patterns workers will be associated with more disrupted biomarker profiles. Among rotating shift workers, night shift will be associated with acute disrupted melatonin production, metabolomic profiles and composition of oral microbiota compared to a day shift.

02

Conditions studied

  • Obesity
  • Shift-work Disorder
  • Circadian Rhythm Disorders
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Vienna is the lead sponsor of 49 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

We are recruiting shift worker and day worker in the industrial and healthcare setting.

Eligibility criteria

Inclusion Criteria shift worker

  • Health care sector or industrial shift worker
  • Employed or self-employed
  • 21 years or older
  • ≥ 24 h/ week
  • Shift work duration > 3 years and currently doing night shifts
  • 4 or more rotating night shifts/month (night shift defined as a work schedule that involves working at least 3 hours between 00:00 and 5:00), at least 2 consecutive nights/month

Inclusion criteria controls

  • Health care sector or industrial work
  • Employed or self-employed
  • 21 years or older
  • ≥ 24 h/ week
  • No night shift or rotating shift work in the last 5 years
  • No history of night shift or rotating shift work for more than 5 years

Exclusion Criteria shift worker and controls:

  • Pregnancy
  • Lactation period
  • of 40 kg/m2 or above
  • Present treatment of a disease e.g. cancer radio- or chemotherapy
  • Chronic diseases if in an ongoing therapy but not after a remission (renal failure, active hepatitis, cirrhosis, myocardial infarction, and cancer)
  • Immunodeficiency syndrome, any auto-immune or auto-inflammatory diseases (e.g. type-1 diabetes, multiple sclerosis, lupus, rheumatoid arthritis) and acute episodes of atopic diseases (atopic dermatitis, asthma, type 1 allergies such as hay fever)
  • Bariatric surgery
  • Antibiotics in the last month
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Nightshift workers

    Nightshift worker in the health care and industrial sector. Night shift is defined as a work schedule that involves working at least 3 hours between 00:00 and 5:00, at least 2 consecutive nights/month.

    Other: No intervention

  • Dayshift workers

    Dayshift worker in the health care and industrial sector. No night shifts.

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. high-sensitive C-Reactive Protein (hs-CRP)

    Compare hs-CRP levels between night shift workers and day shift workers

    Time frame: Baseline

Secondary outcomes

  1. The investigators will consider levels of hormones in plasma

    Compare melatonin levels between night shift workers and day shift workers

    Time frame: Baseline

  2. The investigators will consider levels of hormones in plasma

    Compare cortisol levels between night shift workers and day shift workers

    Time frame: Baseline

  3. The investigators will consider levels of parameters linked to gut health in serum and in feces

    Compare Short-chain fatty acids (SCFA) levels between night shift workers and day shift workers

    Time frame: Baseline

  4. The investigators will consider levels of parameters linked to gut health in serum and in feces

    Compare Fatty acid-binding protein (FABP) levels between night shift workers and day shift workers

    Time frame: Baseline

  5. The investigators will consider levels of parameters linked to gut health in serum and in feces

    Compare lipopolysaccharide(LPS)-binding protein levels between night shift workers and day shift workers

    Time frame: Baseline

  6. The investigators will consider levels of parameters linked to gut health in serum and in feces

    Compare zonulin-1 levels between night shift workers and day shift workers

    Time frame: Baseline

  7. The investigators will consider parameters of cellular immunity and inflammation in plasma

    Compare growth factors levels between night shift workers and day shift workers

    Time frame: Baseline

  8. The investigators will consider parameters of cellular immunity and inflammation in plasma

    Compare cytokines levels between night shift workers and day shift workers

    Time frame: Baseline

  9. The investigators will consider parameters of cellular immunity and inflammation in plasma

    Compare chemokines levels between night shift workers and day shift workers

    Time frame: Baseline

  10. The investigators will consider parameters of metabolism of fat and sugar in plasma

    Compare total cholesterol levels between night shift workers and day shift workers

    Time frame: Baseline

  11. The investigators will consider parameters of metabolism of fat and sugar in plasma

    Compare LDL-C levels between night shift workers and day shift workers

    Time frame: Baseline

  12. The investigators will consider parameters of metabolism of fat and sugar in plasma

    Compare HDL-C levels between night shift workers and day shift workers

    Time frame: Baseline

  13. The investigators will consider parameters of metabolism of fat and sugar in plasma

    Compare triglycerides levels between night shift workers and day shift workers

    Time frame: Baseline

  14. The investigators will consider parameters of metabolism of fat and sugar in plasma

    Compare glucose levels between night shift workers and day shift workers

    Time frame: Baseline

  15. The investigators will consider levels of appetite markers in plasma

    Compare leptin levels between night shift workers and day shift workers

    Time frame: Baseline

  16. The investigators will consider levels of appetite markers in plasma

    Compare ghrelin levels between night shift workers and day shift workers

    Time frame: Baseline

  17. The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine

    Compare DNA damage levels between night shift workers and day shift workers

    Time frame: Baseline

  18. The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine

    Compare Malondialdehyde (MDA) levels between night shift workers and day shift workers

    Time frame: Baseline

  19. The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine

    Compare 8-oxo-Guo/Gua levels between night shift workers and day shift workers

    Time frame: Baseline

  20. The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine

    Compare protein carbonyls levels between night shift workers and day shift workers

    Time frame: Baseline

  21. The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine

    Compare unconjugated bilirubin levels between night shift workers and day shift workers

    Time frame: Baseline

  22. The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS)

    Compare the levels of various metabolites between night shift workers and day shift workers

    Time frame: Baseline

  23. The investigators will consider microbiome analysis of feces samples and tongue swabs

    Compare the levels of various microbiota composition between night shift workers and day shift workers

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06288568
Lead sponsor
University of Vienna
Collaborators
Medical University of Vienna, FH Joanneum Gesellschaft mbH, Wageningen University and Research, Wageningen University, University of Bremen, Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V., UNIVERSYTET MEDYCZNY W LODZI, Københavns Universitet, Charite University, Berlin, Germany, Erasmus Medical Center
Responsible party
Karl-Heinz Wagner (Professor, University of Vienna) — Principal investigator
First posted
Mar 1, 2024
Start date
Apr 1, 2024
Primary completion
Nov 1, 2025 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Sep 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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