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临床试验/NCT06288568
NCT06288568招募中不适用

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

University of Vienna1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
high-sensitive C-Reactive Protein (hs-CRP)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

high-sensitive C-Reactive Protein (hs-CRP)

时间窗: Baseline

Compare hs-CRP levels between night shift workers and day shift workers

次要结局

  • The investigators will consider levels of hormones in plasma(Baseline)
  • The investigators will consider parameters of cellular immunity and inflammation in plasma(Baseline)
  • The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine(Baseline)
  • The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS)(Baseline)
  • The investigators will consider parameters of metabolism of fat and sugar in plasma(Baseline)
  • The investigators will consider microbiome analysis of feces samples and tongue swabs(Baseline)
  • The investigators will consider levels of appetite markers in plasma(Baseline)
  • The investigators will consider levels of parameters linked to gut health in serum and in feces(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karl-Heinz Wagner

Professor

University of Vienna

研究点 (1)

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