NCT04710667

Brief Summary

The gastrointestinal tract contains hundreds of millions of microorganisms, collectively called the intestinal flora, which plays an important role in the health of the host. Many studies have also confirmed that the composition and function of the intestinal flora can be changed through the training chain. Changes in the composition of intestinal microbes can affect exercise performance, energy metabolism, oxidative stress, immune function, inflammation, and tissue repair. Therefore, maintaining a healthy gut microbial balance is essential for athletes' health, training, nutritional status, and athletic performance. This project intends to use metagenomics, proteomics, and metabolomics and other technologies to systematically explore the effects of different training periods and dietary interventions on the intestinal flora of muscle strength and endurance athletes. , Protein expression and the influence of metabolites. In the plan, explore the differences in the intestinal flora between muscle strength and endurance sports athletes during the preparation period, competition period, and transition period, and collect blood and feces to perform protein and metabolite molecular changes. It is hoped that through the smooth implementation of this research project, the research results can be applied to personalized diet planning, improve intestinal adaptability and the effectiveness of sports nutrition intervention, and then adjust athletes' status and improve sports performance to win the highest honor for the country in the arena.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 12, 2021

Last Update Submit

January 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differences in intestinal flora of athletes in sports during preparation, competition and transition periods

    asparate aminotransferase、alanine aminotransferase、albumin、blood urea nitrogen Creatinine、uric acid、total cholesterol、triacylglycerol、High-density lipoprotein、Low density lipoprotein、Free fatty acid、glucose、creatine kinase、gut microbiota

    2021/1/1-2021/2/28

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Recruitment of 12 healthy muscle and endurance athletes from the National Sports University

You may qualify if:

  • years old healthy muscle strength and endurance sports athletes

You may not qualify if:

  • Exclude cardiovascular disease, hypertension, metabolic disease, asthma, or neuromuscular sports injuries within six months, etc.
  • Exclude those who regularly take lactic acid bacteria-related foods for a long time
  • Exclude students and related stakeholders under the guidance of the project host

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Sport University

Taoyuan, 333, Taiwan

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 15, 2021

Study Start

October 30, 2020

Primary Completion

February 3, 2021

Study Completion

February 3, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations