Clinical trial NCT04918537: Analysis of Microbiota Variations in Industry Workers Working Different Shifts and Impact of a Nutritional Intervention
Official title: Analysis of Microbiota Variations in Industry Workers Working Different Shifts and Impact of a Nutritional Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysbiosis
Keywords: Gut microbiota
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2021-06-09
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 3 weeks of observation 3 weeks of intervention
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in gut microbiota composition between the first and last day of each type of shift (observation phase)
timeFrame: 3 weeks (6 measurements over time)
measure: Change in gut microbiota composition between the first and last day of each type of shift (observation vs intervention)
timeFrame: 6 weeks (12 measurements over time)
Secondary outcomes:
measure: Area under the blood glucose curve between each type of shift
timeFrame: 3 weeks
measure: Area under the blood glucose curve in AM shift (observation vs intervention)
timeFrame: week 1 vs 4
Other outcomes:
measure: Mean weekly frequency of defecation between each type of shift
timeFrame: 6 weeks
Locations:
city: Geneva
country: Switzerland
facility: School of Health Sciences Geneva
state: Carouge
Study officials:
References: