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

Dysbiosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04918537
• Other study ID #: G700136106018
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2022
• Source: School of Health Sciences Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis

Intervention

Dietary Supplement:
• Walnuts
30g of plain walnuts in addition to habitual food intakes

Locations

Country	Name	City	State
Switzerland	School of Health Sciences Geneva	Geneva	Carouge

Sponsors (2)

Lead Sponsor	Collaborator
Sophie Bucher Della Torre	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean weekly frequency of defecation between each type of shift		6 weeks
Primary	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)
Primary	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	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
Secondary	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