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

Obesity Clinical Trial

— Shift2Health  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06288568
• Other study ID #: Shift2Health
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: March 2024
• Source: University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2028
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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 2 years

• No history of night shift or rotating shift work for more than 3 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

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Obesity
• Shift-work Disorder

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (11)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high-sensitive C-Reactive Protein (hs-CRP)	Compare hs-CRP levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of hormones in plasma	Compare melatonin levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of hormones in plasma	Compare cortisol levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of parameters linked to gut health in serum and in feces	Compare Short-chain fatty acids (SCFA) levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of parameters linked to gut health in serum and in feces	Compare Fatty acid-binding protein (FABP) levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of parameters linked to gut health in serum and in feces	Compare lipopolysaccharide(LPS)-binding protein levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of parameters linked to gut health in serum and in feces	Compare zonulin-1 levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider parameters of cellular immunity and inflammation in plasma	Compare growth factors levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider parameters of cellular immunity and inflammation in plasma	Compare cytokines levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider parameters of cellular immunity and inflammation in plasma	Compare chemokines levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider parameters of metabolism of fat and sugar in plasma	Compare total cholesterol levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider parameters of metabolism of fat and sugar in plasma	Compare LDL-C levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider parameters of metabolism of fat and sugar in plasma	Compare HDL-C levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider parameters of metabolism of fat and sugar in plasma	Compare triglycerides levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider parameters of metabolism of fat and sugar in plasma	Compare glucose levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of appetite markers in plasma	Compare leptin levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of appetite markers in plasma	Compare ghrelin levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine	Compare DNA damage levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine	Compare Malondialdehyde (MDA) levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine	Compare 8-oxo-Guo/Gua levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine	Compare protein carbonyls levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine	Compare unconjugated bilirubin levels between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS)	Compare the levels of various metabolites between night shift workers and day shift workers	Baseline
Secondary	The investigators will consider microbiome analysis of feces samples and tongue swabs	Compare the levels of various microbiota composition between night shift workers and day shift workers	Baseline