Clinical Trial

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

Study acronym: Shift2Health
Recruiting
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Record status
This record was last updated September 8, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-02-23; most recent amendment 2025-09-05.
Status change: Not Yet Recruiting → Recruiting 2025-02-17
Trial Details
NCT Number 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
Conditions Obesity, Shift-work Disorder, Circadian Rhythm Disorders
Enrollment 1,000 participants
Start Date 2024-04-01
Primary Completion 2025-11-01 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-08