Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers
NCT ID: NCT06288568
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-04-01
2028-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
No intervention
No intervention
Dayshift workers
Dayshift worker in the health care and industrial sector. No night shifts.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
21 Years
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
FH Joanneum Gesellschaft mbH
INDUSTRY
Wageningen University and Research
OTHER
Wageningen University
OTHER
University of Bremen
OTHER
Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.
UNKNOWN
UNIVERSYTET MEDYCZNY W LODZI
UNKNOWN
Københavns Universitet
OTHER
Charite University, Berlin, Germany
OTHER
Erasmus Medical Center
OTHER
University of Vienna
OTHER
Responsible Party
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Karl-Heinz Wagner
Professor
Locations
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Medical University of Vienna
Vienna, Vienna, Austria
Countries
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Facility Contacts
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Other Identifiers
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Shift2Health
Identifier Type: -
Identifier Source: org_study_id
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