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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06288568
Acronym
Shift2Health
Enrollment
1000
Registered
2024-03-01
Start date
2024-04-01
Completion date
2028-05-31
Last updated
2025-09-08

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

Conditions

Circadian Rhythm Disorders, Obesity, Shift-work Disorder

Brief 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.

Interventions

OTHERNo intervention

No intervention

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
high-sensitive C-Reactive Protein (hs-CRP)BaselineCompare hs-CRP levels between night shift workers and day shift workers

Secondary

MeasureTime frameDescription
The investigators will consider levels of hormones in plasmaBaselineCompare melatonin levels between night shift workers and day shift workers
The investigators will consider levels of parameters linked to gut health in serum and in fecesBaselineCompare Short-chain fatty acids (SCFA) levels between night shift workers and day shift workers
The investigators will consider parameters of cellular immunity and inflammation in plasmaBaselineCompare growth factors levels between night shift workers and day shift workers
The investigators will consider parameters of metabolism of fat and sugar in plasmaBaselineCompare total cholesterol levels between night shift workers and day shift workers
The investigators will consider levels of appetite markers in plasmaBaselineCompare leptin levels between night shift workers and day shift workers
The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urineBaselineCompare DNA damage levels between night shift workers and day shift workers
The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS)BaselineCompare the levels of various metabolites between night shift workers and day shift workers
The investigators will consider microbiome analysis of feces samples and tongue swabsBaselineCompare the levels of various microbiota composition between night shift workers and day shift workers

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026