NCT06288568 Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers
| NCT ID | NCT06288568 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Vienna |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-04-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 * 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
Frequently Asked Questions
Who can join the NCT06288568 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06288568 currently recruiting?
Yes, NCT06288568 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Vienna to inquire about joining.
Where is the NCT06288568 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06288568 clinical trial?
NCT06288568 is sponsored by University of Vienna. The trial plans to enroll 1,000 participants.
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