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NCT Number: NCT06288568

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Kyriaki Papantoniou, MD PhD

CONTACT

[email protected]

0043(0)4016034706

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • BMI 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, chronic obstructive pulmonary disease 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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

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

    Time frame: Baseline

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

Secondary outcomes

  1. The investigators will consider levels of hormones in plasma

    Time frame: Baseline

    Compare melatonin levels between night shift workers and day shift workers

  2. The investigators will consider levels of hormones in plasma

    Time frame: Baseline

    Compare cortisol levels between night shift workers and day shift workers

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

    Compare cytokines levels between night shift workers and day shift workers

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

    Time frame: Baseline

    Compare chemokines levels between night shift workers and day shift workers

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

    Compare triglycerides levels between night shift workers and day shift workers

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

    Time frame: Baseline

    Compare glucose levels between night shift workers and day shift workers

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

    Time frame: Baseline

    Compare leptin levels between night shift workers and day shift workers

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

    Time frame: Baseline

    Compare ghrelin levels between night shift workers and day shift workers

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Collaborators

  • Charite University, Berlin, Germany
  • Erasmus Medical Center
  • FH Joanneum Gesellschaft mbH
  • Københavns Universitet
  • Medical University of Vienna
  • UNIVERSYTET MEDYCZNY W LODZI
  • University of Bremen
  • Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.
  • Wageningen University
  • Wageningen University and Research

Registry information

Official study title

Development and Evaluation of Nutritional Strategies to Reduce and Prevent Obesity in Shiftworkers

Acronym: Shift2Health

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Mar 1, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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