AthleteNCT04710667
To Explore the Effects of Different Training Periods and Dietary Pattern on the Gut Microbiota, Metabolites and Protein Expression Levels of Strength and Endurance Athletes and to Find Relevant Biological Indicators.
An observational study of Athlete, run by National Taiwan Sport University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Athlete
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Oct 2020to 3 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Recruitment of 12 healthy muscle and endurance athletes from the National Sports University
Who may be able to join
- 20-30 years old healthy muscle strength and endurance sports athletes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Sport University
Taoyuan City, 333
YuChih Lin, +886961546309, jarling217015@gmail.com
About this study
Official title: Sports Science Institute
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.
- Conditions
- Athlete
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2021/1/1-2021/2/28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start30 Oct 2020
- Primary completion3 Feb 2021 (estimated)
- Study completion3 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthleteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LinYuChih, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710667
- Sponsor's protocol ID
- IRB-19-039-B1
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sports Science Institute
- ClinicalTrials.gov ID
- NCT04710667
- Acronym / sponsor ID
- IRB-19-039-B1
- Conditions
- Athlete
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 3 Feb 2021 (estimated)
- Study completion
- 3 Feb 2021 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recruitment of 12 healthy muscle and endurance athletes from the National Sports University
Key inclusion criteria (1 listed)
- 20-30 years old healthy muscle strength and endurance sports athletes
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in intestinal flora of athletes in sports during preparation, competition and transition periods
Time frame: 2021/1/1-2021/2/28
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athlete, run by National Taiwan Sport University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YuChih Lin (+886961546309, jarling217015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in intestinal flora of athletes in sports during preparation, competition and transition periods (time frame: 2021/1/1-2021/2/28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.