Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-23
Brief Title:
Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers
Sponsor:
University of Vienna
Organization:
University of Vienna
Study Overview
Official Title:
Development and Evaluation of Nutritional Strategies to Reduce and Prevent Obesity in Shiftworkers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Shift2Health
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 200country 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
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 200country 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None