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临床试验/NCT04918537
NCT04918537Unknown不适用

Analysis of Microbiota Variations in Industry Workers Working Different Shifts and Impact of a Nutritional Intervention

Sophie Bucher Della Torre1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
18
试验地点
1
主要终点
Change in gut microbiota composition between the first and last day of each type of shift (observation phase)

研究概览

简要总结

Shift workers are a growing population. It is well established that these workers face an increased risk of developing chronic diseases, but the underlying mechanisms remain debated. Various factors such as internal circadian desynchronization, unhealthy lifestyle behaviours, and lack of sleep interact in complex ways. Recently, it has been suggested that the gut microbiota (GM) may play an important role in this increased risk.

The goal of this study is to describe the variations of the GM composition in shift workers across three different rotating weekly shifts (morning, afternoon, night) and to measure the impact of a 3- week walnuts supplementation intervention consisting in a controlled experimental study.

Therefore, we propose a 6-weeks study including an observational and an experimental part. First, in the observational part, we will compare the gut microbiota of shift workers across three shifts (morning, afternoon and night). In the second part of the study, participants will add to their usual intakes a daily serving of nuts (30g). Again, we will compare the gut microbiota composition across the three types of shifts. During the study, participants will record their food intake, sleep and defecation time. We will also monitor their blood glucose levels continuously during the 4 first weeks of the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Working 3x8 shifts (weekly rotations between AM, PM and N shifts) for at least 3 months prior to the study
  • •No anticipated changes in shift work planning
  • •No prebiotics or probiotics supplements.

排除标准

  • •Antibiotic and/or immunomodulator use in the last 3 months or during the study
  • •Change in medication during the last month or during study
  • •Inflammatory bowel disease or important gut surgery
  • •Nuts allergy
  • •Major digestive tract surgery.

研究组 & 干预措施

Intervention walnuts

Experimental

During the 3 last weeks of the study, the participants will eat a 30g daily walnut serving

干预措施: Walnuts (Dietary Supplement)

结局指标

主要结局

Change in gut microbiota composition between the first and last day of each type of shift (observation phase)

时间窗: 3 weeks (6 measurements over time)

Change in relative abundance of bacteria phyla between the first and last day of each type of shift (AM, PM, N). Assessed by 16S rRNA sequencing approach.

Change in gut microbiota composition between the first and last day of each type of shift (observation vs intervention)

时间窗: 6 weeks (12 measurements over time)

Change in relative abundance of bacteria phyla between the first and last day of each type of shift (AM, PM, N). Assessed by 16S rRNA sequencing approach.

次要结局

  • Area under the blood glucose curve between each type of shift(3 weeks)
  • Area under the blood glucose curve in AM shift (observation vs intervention)(week 1 vs 4)

研究者

发起方
Sophie Bucher Della Torre
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sophie Bucher Della Torre

Professor Assistant

School of Health Sciences Geneva

研究点 (1)

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