ObesityShift2HealthNCT06288568
Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers
An observational study of Obesity and Shift-work Disorder, run by University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Shift-work Disorder, Circadian Rhythm Disorders
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2024to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We are recruiting shift worker and day worker in the industrial and healthcare setting.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Kyriaki Papantoniou, MD PhD, 0043(0)4016034706, kyriaki.papantoniou@meduniwien.ac.at
About this study
Official title: Development and Evaluation of Nutritional Strategies to Reduce and Prevent Obesity in Shiftworkers
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.
- Conditions
- Obesity, Shift-work Disorder, Circadian Rhythm Disorders
- Being tested
- No intervention
- Medical subject headings
- Obesity, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Nightshift workers | Nightshift worker in the health care and industrial sector. Night shift is defined as a work schedule that involves working at least 3 hours between 00:00 and 5:00, at least 2 consecutive nights/month. Receives: Other: No intervention | |
| Dayshift workers | Dayshift worker in the health care and industrial sector. No night shifts. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-sensitive C-Reactive Protein (hs-CRP)
Compare hs-CRP levels between night shift workers and day shift workers
Measured: Baseline
Secondary outcomes (23)
The investigators will consider levels of hormones in plasma
Compare melatonin levels between night shift workers and day shift workers
Measured: Baseline
The investigators will consider levels of hormones in plasma
Compare cortisol levels between night shift workers and day shift workers
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
The investigators will consider parameters of cellular immunity and inflammation in plasma
Compare growth factors levels between night shift workers and day shift workers
Measured: Baseline
The investigators will consider parameters of cellular immunity and inflammation in plasma
Compare cytokines levels between night shift workers and day shift workers
Measured: Baseline
The investigators will consider parameters of cellular immunity and inflammation in plasma
Compare chemokines levels between night shift workers and day shift workers
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
The investigators will consider parameters of metabolism of fat and sugar in plasma
Compare triglycerides levels between night shift workers and day shift workers
Measured: Baseline
The investigators will consider parameters of metabolism of fat and sugar in plasma
Compare glucose levels between night shift workers and day shift workers
Measured: Baseline
The investigators will consider levels of appetite markers in plasma
Compare leptin levels between night shift workers and day shift workers
Measured: Baseline
The investigators will consider levels of appetite markers in plasma
Compare ghrelin levels between night shift workers and day shift workers
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Karl-Heinz Wagner, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288568
- Sponsor's protocol ID
- Shift2Health
- Acronym
- Shift2Health
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Nutritional Strategies to Reduce and Prevent Obesity in Shiftworkers
- ClinicalTrials.gov ID
- NCT06288568
- Acronym / sponsor ID
- Shift2Health / Shift2Health
- Conditions
- Obesity, Shift-work Disorder, Circadian Rhythm Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- 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
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nightshift workers | – | Other: No interventionNightshift worker in the health care and industrial sector. Night shift is defined as a work schedule that involves working at least 3 hours between 00:00 and 5:00, at least 2 consecutive nights/month. |
| Dayshift workers | – | Other: No interventionDayshift worker in the health care and industrial sector. No night shifts. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We are recruiting shift worker and day worker in the industrial and healthcare setting.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Dayshift workers, Nightshift workers |
Primary outcome
high-sensitive C-Reactive Protein (hs-CRP)
Time frame: Baseline
Compare hs-CRP levels between night shift workers and day shift workers
23 secondary outcomes
The investigators will consider levels of hormones in plasma
Time frame: Baseline
The investigators will consider levels of hormones in plasma
Time frame: Baseline
The investigators will consider levels of parameters linked to gut health in serum and in feces
Time frame: Baseline
The investigators will consider levels of parameters linked to gut health in serum and in feces
Time frame: Baseline
The investigators will consider levels of parameters linked to gut health in serum and in feces
Time frame: Baseline
The investigators will consider levels of parameters linked to gut health in serum and in feces
Time frame: Baseline
The investigators will consider parameters of cellular immunity and inflammation in plasma
Time frame: Baseline
The investigators will consider parameters of cellular immunity and inflammation in plasma
Time frame: Baseline
The investigators will consider parameters of cellular immunity and inflammation in plasma
Time frame: Baseline
The investigators will consider parameters of metabolism of fat and sugar in plasma
Time frame: Baseline
The investigators will consider parameters of metabolism of fat and sugar in plasma
Time frame: Baseline
The investigators will consider parameters of metabolism of fat and sugar in plasma
Time frame: Baseline
The investigators will consider parameters of metabolism of fat and sugar in plasma
Time frame: Baseline
The investigators will consider parameters of metabolism of fat and sugar in plasma
Time frame: Baseline
The investigators will consider levels of appetite markers in plasma
Time frame: Baseline
The investigators will consider levels of appetite markers in plasma
Time frame: Baseline
The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
Time frame: Baseline
The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
Time frame: Baseline
The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
Time frame: Baseline
The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
Time frame: Baseline
The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine
Time frame: Baseline
The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS)
Time frame: Baseline
The investigators will consider microbiome analysis of feces samples and tongue swabs
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Shift-work Disorder, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-sensitive C-Reactive Protein (hs-CRP) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.