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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dysbiosis

Intervention / Treatment
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* Dietary Supplement: Walnuts


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Sequential Assignment
Interventional Model Description: 3 weeks of observation 3 weeks of intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention walnuts<br>During the 3 last weeks of the study, the participants will eat a 30g daily walnut serving | Dietary Supplement: Walnuts<br>* 30g of plain walnuts in addition to habitual food intakes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gut microbiota composition between the first and last day of each type of shift (observation phase) | 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. | 3 weeks (6 measurements over time) | 
| Change in gut microbiota composition between the first and last day of each type of shift (observation vs intervention) | 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. | 6 weeks (12 measurements over time) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the blood glucose curve between each type of shift | Area under the blood glucose curve between each type of shift (AM, PM, N). Measured using a continuous glucose monitoring. | 3 weeks | 
| Area under the blood glucose curve in AM shift (observation vs intervention) | Area under the blood glucose curve during the morning shift (AM) during the observation and the intervention. Measured using a continuous glucose monitoring. | week 1 vs 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiota