MicrobiomeNCT04611945
Westlake Sailing Cohort
An observational study of Microbiome and Glucose Metabolism, run by Westlake University at 1 site in China.
Trial summary
Little is known about the dynamic change of human microbiome in different body sites including skin, mouth and gut during sailing. The present study aims to reveal the change of human microbiome in response to the sailing environment in a 1-month period, and its implication for human health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiome, Glucose Metabolism, Mood
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to 26 Apr 2022
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who will sail by Shenkuo, a scientific research ship, December 2020.
Who may be able to join
- Willingness and capability to complete the study protocol
Who cannot join
- Inability or unwillingness to approved to provide informed consent.
- Women who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Westlake Sailing Cohort: Dynamic Change of Human Microbiome During Sailing
Little is known about the dynamic change of human microbiome in different body sites including skin, mouth and gut during sailing. The present study aims to reveal the change of human microbiome in response to the sailing environment in a 1-month period, and its implication for human health.
Read the detailed description
This study will recruit a number of participants who are going to sail for mariana trench from Shenzhen, China. Characteristics of the participants will be described by a series of index of stool, urine, skin microbiota and tongue coating. All the biospecimen will be collected before and during the voyage. Stool at the 2nd, the 4th and the 12th week after the voyage and blood sample at the baseline will also be collected. Participants' mood states, health-related quality of life, fatigue score and sleep quality will be investigated with questionnaires throughout the 1-month period. Participants are asked to record diseases and symptoms, if any, when sailing. All the data will be used to analyse how microbiota change and be involved in human health during a voyage.
- Conditions
- Microbiome, Glucose Metabolism, Mood, Environment
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbial abundant change
Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Measured: Day 1, day 10, day 16, day 23, day 28
Tongue coating microbial abundant change
Tongue coating microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Measured: Day 1, day 10, day 16, day 23, day 28
Secondary outcomes (8)
Mood states change over 4 weeks
Transient, fluctuating feelings, and enduring affect states will be assessed by the Profile of Mood States-Short Form (POMS-SF) . POMS-SF contains 30 questions that assess the following seven different moods: anger-hostility (AH), confusion-bewilderment (CB), depression-dejection (DD), fatigue-inertia (FI), tension-anxiety (TA), vigoractivity (VA), and friendliness (F). Total mood disturbance (TMD) scores were calculated based on the previous seven factors. High scores for VA and F indicate a positive mood state, while high scores for AH, CB, DD, FI, TA, and TMD indicate a negative mood state.
Measured: Day 1, day 10, day 16, day 23, day 30
Health-related quality of life change over the one-month sailing
Health-related quality of life will be assessed by the Short-Form 36 Health Status Questionnaire（SF-36). It contains eight subscales scoring from 0 to 100 points for each, with higher scores indicating better quality of life.
Measured: Day 1, day 30
Sleep quality change over the one-month sailing
The Pittsburgh Sleep Quality Index （PSQI）will be used to assess sleep quality. It comprises 19 items for self-reported sleep quality in the last month and five additional questions to be answered by roommates, if applicable. The 19 items are grouped into seven component scores: sleep quality, sleep latency, sleep duration, efficiency of habitual sleep, sleep disturbance, use of sleep medication, and diurnal dysfunction. These are then added to a global PSQI score. The PSQI score ranges from 0 to 21, with a higher score indicative of poorer sleep quality.
Measured: Day 1, day 30
Short-chain fatty acids change
Short-chain fatty acids will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).
Measured: Day 1, day 10, day 16, day 23, day 28
Weight change
Weight will be described by kilogram.
Measured: Day 1, day 10, day 16, day 23, day 28
Blood pressure change
Systolic pressure and diastolic pressure will be measured and described by mmHg.
Measured: Day 1, day 10, day 16, day 23, day 28
Fatigue score change
The Multi-dimensional Fatigue Inventory (MFI-20) will be used to measure aspects of fatigue experienced during the previous days. It consists of five subscales of fatigue: general fatigue (GF), physical fatigue (PF), re-duced motivation (RM), reduced activity (RA), and mental fatigue (MF). The score ranges from 20 to 100. Higher scores indicate a higher degree of fatigue.
Measured: Day 1, day 10, day 16, day 23, day 30
Skin microbial abundant change
Skin microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Measured: Day 1, day 10, day 16, day 23, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start10 Nov 2020
- Primary completion31 Jan 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ju-Sheng Zheng, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611945
- Sponsor's protocol ID
- 20200911ZJS001
- Status last verified
- Apr 2022
- First submitted
- 9 Oct 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Westlake Sailing Cohort: Dynamic Change of Human Microbiome During Sailing
- ClinicalTrials.gov ID
- NCT04611945
- Acronym / sponsor ID
- 20200911ZJS001
- Conditions
- Microbiome, Glucose Metabolism, Mood, Environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 2 Nov 2020 (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.
Little is known about the dynamic change of human microbiome in different body sites including skin, mouth and gut during sailing. The present study aims to reveal the change of human microbiome in response to the sailing environment in a 1-month period, and its implication for human health.
Detailed description
This study will recruit a number of participants who are going to sail for mariana trench from Shenzhen, China. Characteristics of the participants will be described by a series of index of stool, urine, skin microbiota and tongue coating. All the biospecimen will be collected before and during the voyage. Stool at the 2nd, the 4th and the 12th week after the voyage and blood sample at the baseline will also be collected. Participants' mood states, health-related quality of life, fatigue score and sleep quality will be investigated with questionnaires throughout the 1-month period. Participants are asked to record diseases and symptoms, if any, when sailing. All the data will be used to analyse how microbiota change and be involved in human health during a voyage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who will sail by Shenkuo, a scientific research ship, December 2020.
Key inclusion criteria (1 listed)
- Willingness and capability to complete the study protocol
Key exclusion criteria (2 listed)
- Inability or unwillingness to approved to provide informed consent.
- Women who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbial abundant change
Time frame: Day 1, day 10, day 16, day 23, day 28
Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Tongue coating microbial abundant change
Time frame: Day 1, day 10, day 16, day 23, day 28
Tongue coating microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
8 secondary outcomes
Mood states change over 4 weeks
Time frame: Day 1, day 10, day 16, day 23, day 30
Health-related quality of life change over the one-month sailing
Time frame: Day 1, day 30
Sleep quality change over the one-month sailing
Time frame: Day 1, day 30
Short-chain fatty acids change
Time frame: Day 1, day 10, day 16, day 23, day 28
Weight change
Time frame: Day 1, day 10, day 16, day 23, day 28
Blood pressure change
Time frame: Day 1, day 10, day 16, day 23, day 28
Fatigue score change
Time frame: Day 1, day 10, day 16, day 23, day 30
Skin microbial abundant change
Time frame: Day 1, day 10, day 16, day 23, day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Microbiome
Not yet recruiting
Supplementation of Inulin + L. Acidophilus in Elders With T2DM
Diabetes Mellitus, Microbiome
Recruiting
Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment
Microbiome
Active, not recruitingObservational study
Microbiome Characterization in Fatty Pancreas
Fatty Pancreas, Microbiome Analysis
Recruiting
Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
Microbiome
Active, not recruitingObservational study
Study on the Impact of Different Feeding Methods on Allergy Prevention and Digestive Absorption in Infants and Young Children
Infant Allergy, Infant Gut Health
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.
Ju-Sheng Zheng principal investigator
Westlake University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiome and Glucose Metabolism, run by Westlake University at 1 site in China.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gut microbial abundant change (time frame: Day 1, day 10, day 16, day 23, day 28). 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 28 Apr 2022; AzTrials last refreshed its copy on 29 Oct 2026.