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

Not Applicable

• Conditions: Dysbiosis
• Interventions: Dietary Supplement: Walnuts

• Registration Number: NCT04918537
• Lead Sponsor: Sophie Bucher Della Torre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-12
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-09
• Primary Completion: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-16
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention walnuts	Walnuts	During the 3 last weeks of the study, the participants will eat a 30g daily walnut serving

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Health Sciences Geneva; 🇨🇭 Geneva, Carouge, Switzerland