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NCT Number: NCT04611945

Westlake Sailing Cohort

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.

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Key information

Conditions

Microbiome Environment Glucose Metabolism Mood

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Westlake University

Hangzhou, Zhejiang, 310024, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Mood states change over 4 weeks

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 1, day 10, day 16, day 23, day 28

    Weight will be described by kilogram.

  6. Blood pressure change

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Registry information

Official study title

Westlake Sailing Cohort: Dynamic Change of Human Microbiome During Sailing

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2020
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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