Clinical trial NCT06288568: Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers
Official title: Development and Evaluation of Nutritional Strategies to Reduce and Prevent Obesity in Shiftworkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Shift-work Disorder
Circadian Rhythm Disorders
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: FH Joanneum Gesellschaft mbH
name: Wageningen University and Research
name: Wageningen University
name: University of Bremen
name: Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.
name: UNIVERSYTET MEDYCZNY W LODZI
name: Københavns Universitet
name: Charite University, Berlin, Germany
name: Erasmus Medical Center
First posted: 2024-03-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are recruiting shift worker and day worker in the industrial and healthcare setting.

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
* ≥ 28 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
* ≥ 28 h/ week
* No night shift or rotating shift work in the last 10 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 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

Primary outcomes:
measure: high-sensitive C-Reactive Protein (hs-CRP)
timeFrame: Baseline
Secondary outcomes:
measure: The investigators will consider levels of hormones in plasma
timeFrame: Baseline
measure: The investigators will consider levels of hormones in plasma
timeFrame: Baseline
measure: The investigators will consider levels of parameters linked to gut health in serum and in feces
timeFrame: Baseline
measure: The investigators will consider levels of parameters linked to gut health in serum and in feces
timeFrame: Baseline
measure: The investigators will consider levels of parameters linked to gut health in serum and in feces
timeFrame: Baseline
measure: The investigators will consider levels of parameters linked to gut health in serum and in feces
timeFrame: Baseline
measure: The investigators will consider parameters of cellular immunity and inflammation in plasma
timeFrame: Baseline
measure: The investigators will consider parameters of cellular immunity and inflammation in plasma
timeFrame: Baseline
measure: The investigators will consider parameters of cellular immunity and inflammation in plasma
timeFrame: Baseline
measure: The investigators will consider parameters of metabolism of fat and sugar in plasma
timeFrame: Baseline
measure: The investigators will consider parameters of metabolism of fat and sugar in plasma
timeFrame: Baseline
measure: The investigators will consider parameters of metabolism of fat and sugar in plasma
timeFrame: Baseline
measure: The investigators will consider parameters of metabolism of fat and sugar in plasma
timeFrame: Baseline
measure: The investigators will consider parameters of metabolism of fat and sugar in plasma
timeFrame: Baseline
measure: The investigators will consider levels of appetite markers in plasma
timeFrame: Baseline
measure: The investigators will consider levels of appetite markers in plasma
timeFrame: Baseline
measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
timeFrame: Baseline
measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
timeFrame: Baseline
measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
timeFrame: Baseline
measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
timeFrame: Baseline
measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
timeFrame: Baseline
measure: The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS)
timeFrame: Baseline
measure: The investigators will consider microbiome analysis of feces samples and tongue swabs
timeFrame: Baseline
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: