Westlake Sailing Cohort

Sponsor
Westlake University (Other)
Overall Status
Completed
CT.gov ID
NCT04611945
Collaborator
(none)
17
1
17.5
1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    17 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Westlake Sailing Cohort: Dynamic Change of Human Microbiome During Sailing
    Actual Study Start Date :
    Nov 10, 2020
    Actual Primary Completion Date :
    Jan 31, 2022
    Actual Study Completion Date :
    Apr 26, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Gut microbial abundant change [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.

    2. Tongue coating microbial abundant change [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.

    Secondary Outcome Measures

    1. Mood states change over 4 weeks [Day 1, day 10, day 16, day 23, day 30]

      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.

    2. Health-related quality of life change over the one-month sailing [Day 1, day 30]

      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.

    3. Sleep quality change over the one-month sailing [Day 1, day 30]

      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.

    4. Short-chain fatty acids change [Day 1, day 10, day 16, day 23, day 28]

      Short-chain fatty acids will be analysed by performing liquid chromatography/quadrupole time-of-flight mass spectrometry (LC/Q-TOF/MS).

    5. Weight change [Day 1, day 10, day 16, day 23, day 28]

      Weight will be described by kilogram.

    6. Blood pressure change [Day 1, day 10, day 16, day 23, day 28]

      Systolic pressure and diastolic pressure will be measured and described by mmHg.

    7. Fatigue score change [Day 1, day 10, day 16, day 23, day 30]

      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.

    8. Skin microbial abundant change [Day 1, day 10, day 16, day 23, day 28]

      Skin microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Westlake University Hangzhou Zhejiang China 310024

    Sponsors and Collaborators

    • Westlake University

    Investigators

    • Principal Investigator: Ju-Sheng Zheng, Westlake University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Westlake University
    ClinicalTrials.gov Identifier:
    NCT04611945
    Other Study ID Numbers:
    • 20200911ZJS001
    First Posted:
    Nov 2, 2020
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 28, 2022