Westlake Sailing Cohort

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.

Study Overview

• Status: Completed
• Conditions: Environment; Mood; Glucose Metabolism; Microbiome

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310024
      • Westlake University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who will sail by Shenkuo, a scientific research ship, December 2020.

Description

Inclusion Criteria:

• Willingness and capability to complete the study protocol

Exclusion Criteria:

• Inability or unwillingness to approved to provide informed consent.
• Women who are pregnant or lactating.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbial abundant change	Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.	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.	Day 1, day 10, day 16, day 23, day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	Day 1, day 10, day 16, day 23, day 28
Weight change	Weight will be described by kilogram.	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.	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.	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.	Day 1, day 10, day 16, day 23, day 28

Collaborators and Investigators

• Sponsor: Westlake University
• Investigators: Principal Investigator: Ju-Sheng Zheng, Westlake University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2020
• Primary Completion (ACTUAL): January 31, 2022
• Study Completion (ACTUAL): April 26, 2022

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (ACTUAL): November 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20200911ZJS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No