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

Primary Purpose

Dysbiosis

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Walnuts
Sponsored by
Sophie Bucher Della Torre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysbiosis focused on measuring Gut microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Health Sciences Geneva

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention walnuts

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 2, 2021
Last Updated
May 12, 2022
Sponsor
Sophie Bucher Della Torre
Collaborators
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04918537
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sophie Bucher Della Torre
Collaborators
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysbiosis
Keywords
Gut microbiota

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
3 weeks of observation 3 weeks of intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention walnuts
Arm Type
Experimental
Arm Description
During the 3 last weeks of the study, the participants will eat a 30g daily walnut serving
Intervention Type
Dietary Supplement
Intervention Name(s)
Walnuts
Intervention Description
30g of plain walnuts in addition to habitual food intakes
Primary Outcome Measure Information:
Title
Change in gut microbiota composition between the first and last day of each type of shift (observation phase)
Description
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.
Time Frame
3 weeks (6 measurements over time)
Title
Change in gut microbiota composition between the first and last day of each type of shift (observation vs intervention)
Description
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.
Time Frame
6 weeks (12 measurements over time)
Secondary Outcome Measure Information:
Title
Area under the blood glucose curve between each type of shift
Description
Area under the blood glucose curve between each type of shift (AM, PM, N). Measured using a continuous glucose monitoring.
Time Frame
3 weeks
Title
Area under the blood glucose curve in AM shift (observation vs intervention)
Description
Area under the blood glucose curve during the morning shift (AM) during the observation and the intervention. Measured using a continuous glucose monitoring.
Time Frame
week 1 vs 4
Other Pre-specified Outcome Measures:
Title
Mean weekly frequency of defecation between each type of shift
Time Frame
6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
School of Health Sciences Geneva
City
Geneva
State/Province
Carouge
ZIP/Postal Code
1227
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measure will be made available.
IPD Sharing Time Frame
Data will be available within 12 months of study completion
IPD Sharing 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.

Learn more about this trial

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

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