Westlake Sailing Cohort

Mood Clinical Trial

Official title:

Westlake Sailing Cohort: Dynamic Change of Human Microbiome During Sailing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611945
• Other study ID #: 20200911ZJS001
• Status: Completed
• Start date: November 10, 2020
• Est. completion date: April 26, 2022

Study information

• Verified date: April 2022
• Source: Westlake University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 26, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Environment
• Glucose Metabolism
• Microbiome
• Mood

Locations

Country	Name	City	State
China	Westlake University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Westlake University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Weight change	Weight will be described by kilogram.	Day 1, day 10, day 16, day 23, day 28
Secondary	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
Secondary	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
Secondary	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