DysbiosisNCT04918537
Analysis of Microbiota Variations in Industry Workers Working Different Shifts and Impact of a Nutritional Intervention
A study testing Walnuts in people with Dysbiosis, run by Sophie Bucher Della Torre at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis
- What is being tested?
- Walnuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Apr 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Walnuts
- Keywords
- Gut microbiota
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalnutsDietary supplement
30g of plain walnuts in addition to habitual food intakes
| Study group | Role | What they receive |
|---|---|---|
| Intervention walnuts | Experimental | During the 3 last weeks of the study, the participants will eat a 30g daily walnut serving Receives: Dietary Supplement: Walnuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks (12 measurements over time)
Secondary outcomes (2)
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.
Measured: 3 weeks
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.
Measured: week 1 vs 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start12 Apr 2021
- Primary completion31 Mar 2022
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3 weeks of observation 3 weeks of intervention
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophie Bucher Della Torre
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Sophie Bucher Della Torre, School of Health Sciences Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918537
- Sponsor's protocol ID
- G700136106018
- Status last verified
- May 2022
- First submitted
- 2 Jun 2021
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measure will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Microbiota Variations in Industry Workers Working Different Shifts and Impact of a Nutritional Intervention
- ClinicalTrials.gov ID
- NCT04918537
- Acronym / sponsor ID
- G700136106018
- Conditions
- Dysbiosis
- Keywords
- Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sophie Bucher Della TorreUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 weeks of observation 3 weeks of intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention walnuts | Experimental | Dietary Supplement: WalnutsDuring the 3 last weeks of the study, the participants will eat a 30g daily walnut serving |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walnuts30g of plain walnuts in addition to habitual food intakes | Dietary supplement | Intervention walnuts |
Primary outcome
Change in gut microbiota composition between the first and last day of each type of shift (observation phase)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Area under the blood glucose curve between each type of shift
Time frame: 3 weeks
Area under the blood glucose curve in AM shift (observation vs intervention)
Time frame: week 1 vs 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measure will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnuts in people with Dysbiosis, run by Sophie Bucher Della Torre at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiota composition between the first and last day of each type of shift (observation phase) (time frame: 3 weeks (6 measurements over time)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.