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

NCT04918537 | Unknown DMC

• 1 other identifier: G700136106018
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysbiosis

Keywords

Gut microbiota

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Other Outcomes (1)

• Mean weekly frequency of defecation between each type of shift

  6 weeks

Study Arms (1)

Intervention walnuts

EXPERIMENTAL

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

Dietary Supplement: Walnuts

Interventions

Walnuts DIETARY_SUPPLEMENT

30g of plain walnuts in addition to habitual food intakes

Intervention walnuts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sophie Bucher Della Torre: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

School of Health Sciences Geneva

Geneva, Carouge, 1227, Switzerland

Location

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Assistant

Model Details: 3 weeks of observation 3 weeks of intervention

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 9, 2021
• Study Start: April 12, 2021
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 12 months of study completion
• Access Criteria: At the end of the project the data will be deposited in the Yareta repository developed by the University of Geneva OR in an institutional repository. This choice will ensure that data is archived and shared in accordance with FAIR principles.

Locations

CH (1)