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

Sophie Bucher Della Torre

Status: Unknown

Conditions: Dysbiosis

Treatments: Dietary Supplement: Walnuts

Study type: Interventional

Funder types: Other

Identifiers

NCT04918537

G700136106018

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Intervention walnuts

Experimental group

Description:

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

Treatment:

Dietary Supplement: Walnuts