Marathon RunnerNCT06670742
Gut-muscle Axis: Exploring the Gut Microbiota Influences Host Energy Sources and Exercise Performance
A study testing running in people with Marathon Runner, run by National Taiwan Sport University.
Trial summary
Through training, the investigators can adjust the composition and functions of gut microbiota. Exercise also alters the body's energy metabolism pathways, which, in turn, impacts the gut microbiota and its metabolic products. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Marathon Runner
- What is being tested?
- running
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2024to 31 Dec 2024
- Phase
- Interventional
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Training frequency of at least 3 times per week in the past year, with each session involving at least 1 hour of running.
- Participation in at least 2 marathon events within the past 2 years, with a completion time of under 4 hours and 30 minutes for a full marathon, or under 2 hours and 15 minutes for a half marathon.
- Generally healthy, untrained individuals.
Who cannot join
- Excludes individuals with cardiovascular diseases, hypertension, epilepsy, bronchitis, severe asthma, heart disease, inflammatory bowel disease, bacterial or viral infections, disabilities, or chronic bone diseases.
- Habitual smokers.
- Individuals with highly irregular eating habits or sleep patterns due to shift work or night work.
- History of chronic neuro-muscular injuries or disorders in the past 6 months.
- Individuals who have received antibiotic treatment or taken probiotic supplements in the past 6 months.
- General Healthy Adult Group
Show all 11Show fewer
- Excludes individuals with cardiovascular diseases, hypertension, epilepsy, bronchitis, severe asthma, heart disease, inflammatory bowel disease, bacterial or viral infections, disabilities, or chronic bone diseases.
- Habitual smokers.
- Individuals with highly irregular eating habits or sleep patterns due to shift work or night work.
- History of chronic neuro-muscular injuries or disorders in the past 6 months.
- Individuals who have received antibiotic treatment or taken probiotic supplements in the past 6 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Gut-muscle Axis: Exploring the Gut Microbiota Influences Host Energy Sources and Exercise Performance Via Modulation of Lactate Metabolism and Utilization
Through training, the investigators can adjust the composition and functions of gut microbiota. Exercise also alters the body's energy metabolism pathways, which, in turn, impacts the gut microbiota and its metabolic products. Understanding how the body utilizes and regulates energy during exercise is essential for enhancing athletic performance. This study aims to explore the relationships among post-exercise energy metabolites, gut microbiota, and their metabolic products, applying omics technologies in the field of sports science.
This interdisciplinary research will contribute to fields such as exercise physiology, sports nutrition, exercise biochemistry, and sports medicine, providing innovative and practical research insights for advancing sports science in our country.
Read the detailed description
The gut microbiota, which is comprised of trillions of microbes, is the collective term for the gut microbiota. It establishes a symbiotic relationship with the host and plays a vital role in maintaining host health. Through training, the investigators can adjust the composition and functions of gut microbiota. Exercise also alters the body's energy metabolism pathways, which, in turn, impacts the gut microbiota and its metabolic products. Understanding how the body utilizes and regulates energy during exercise is essential for enhancing athletic performance. This study aims to explore the relationships among post-exercise energy metabolites, gut microbiota, and their metabolic products, applying omics technologies in the field of sports science.
This interdisciplinary research will contribute to fields such as exercise physiology, sports nutrition, exercise biochemistry, and sports medicine, providing innovative and practical research insights for advancing sports science in our country.
- Conditions
- Marathon Runner
- Being tested
- running
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
runningDevice
Running 10 kilometers on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| Marathon running group | Experimental | Run 10 kilometers on a treadmill. Receives: Device: running |
| General healthy adult group | No intervention | No intervention will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of lactate
Measure changes in lactate concentration.
Measured: The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, immediately after exercise, and at 5, 15, 30, and 60 minutes post-exercise.
Concentration of creatine kinase
Measure changes in creatine kinase concentration.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Concentration of glucose
Measure changes in glucose concentration.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Concentration of creatinine
Measure changes in creatinine concentration.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Concentration of blood urea nitrogen
Measure changes in blood urea nitrogen concentration.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Concentration of lactate dehydrogenase
Measure changes in lactate dehydrogenase concentration.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Concentration of free fatty acid
Measure changes in free fatty acid concentration.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Concentration of cortisol
Measure changes in cortisol concentration.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
ood frequency questionnaire(FFQ)
The participants' diets were assessed using a semiquantitative food frequency questionnaire(FFQ). The FFQ used in this study was validated in a previous study; the questionnaire exhibited reliability and validity for identifying major nutrients in the diets of Taiwanese vegetarians and omnivores.(Chiu TH et al., 2014) In this study, the nutrient analysis programme used to calculate the results of the FFQ was based on Taiwan's Food Composition Database. To assess the intake frequency of each food item, frequencies ranged from "never" or "<1 time per month" to "more than 2 times per day.
Measured: Before exercise
Gut microbiota analysis
Collect participant stool samples for gut microbiota analysis.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and at 24 and 48 hours post-exercise.
Untargeted metabolome analysis
Collect participant stool samples for metabolome analysis.Metabolite identification aims to analyze the metabolome composition of biological samples, investigate the regulation of metabolic pathways, and explore biochemical mechanisms.
Measured: The testing time points are set as follows: before exercise, immediately after exercise, and at 24 and 48 hours post-exercise.
Secondary outcomes (3)
Body composition
The investigators used the InBody 570 (In-body, Seoul, South Korea), the bioelectrical impedance analyzer (BIA) to measure body composition. The device can screen frequencies of 1, 5, 50, 260, 500 and 1000 kHz within 60 seconds. After cleaning the palms and soles of the feet, the subject stood vertically on the electrodes of the instrument, holding the sensing handle with both hands and keeping the arms away from the body at a 30° angle, and avoided talking or moving during the measurement. The device measured body weight (kg), BMI (kg/m²), fat mass (%), and lean mass (kg).
Measured: Before exercise
Rate of Perceived Exertion(RPE)
Assess perceived exercise intensity.
Measured: The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, and immediately after exercise.
Heart rate
Assess changes in heart rate.
Measured: The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, and immediately after exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start8 Nov 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marathon RunnerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ju Hsu, National Taiwan Sport University
- Investigators
- Yi-Ju Hsu, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670742
- Sponsor's protocol ID
- NTSUIRB - 112 - 007
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 1 Nov 2024
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut-muscle Axis: Exploring the Gut Microbiota Influences Host Energy Sources and Exercise Performance Via Modulation of Lactate Metabolism and Utilization
- ClinicalTrials.gov ID
- NCT06670742
- Acronym / sponsor ID
- NTSUIRB - 112 - 007
- Conditions
- Marathon Runner
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 8 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Nov 2024 (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.
Through training, the investigators can adjust the composition and functions of gut microbiota. Exercise also alters the body's energy metabolism pathways, which, in turn, impacts the gut microbiota and its metabolic products. Understanding how the body utilizes and regulates energy during exercise is essential for enhancing athletic performance. This study aims to explore the relationships among post-exercise energy metabolites, gut microbiota, and their metabolic products, applying omics technologies in the field of sports science.
This interdisciplinary research will contribute to fields such as exercise physiology, sports nutrition, exercise biochemistry, and sports medicine, providing innovative and practical research insights for advancing sports science in our country.
Detailed description
The gut microbiota, which is comprised of trillions of microbes, is the collective term for the gut microbiota. It establishes a symbiotic relationship with the host and plays a vital role in maintaining host health. Through training, the investigators can adjust the composition and functions of gut microbiota. Exercise also alters the body's energy metabolism pathways, which, in turn, impacts the gut microbiota and its metabolic products. Understanding how the body utilizes and regulates energy during exercise is essential for enhancing athletic performance. This study aims to explore the relationships among post-exercise energy metabolites, gut microbiota, and their metabolic products, applying omics technologies in the field of sports science.
This interdisciplinary research will contribute to fields such as exercise physiology, sports nutrition, exercise biochemistry, and sports medicine, providing innovative and practical research insights for advancing sports science in our country.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marathon running group | Experimental | Device: runningRun 10 kilometers on a treadmill. |
| General healthy adult group | No intervention | –No intervention will be conducted. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Training frequency of at least 3 times per week in the past year, with each session involving at least 1 hour of running.
- Participation in at least 2 marathon events within the past 2 years, with a completion time of under 4 hours and 30 minutes for a full marathon, or under 2 hours and 15 minutes for a half marathon.
- Generally healthy, untrained individuals.
Key exclusion criteria (11 listed)
- Excludes individuals with cardiovascular diseases, hypertension, epilepsy, bronchitis, severe asthma, heart disease, inflammatory bowel disease, bacterial or viral infections, disabilities, or chronic bone diseases.
- Habitual smokers.
- Individuals with highly irregular eating habits or sleep patterns due to shift work or night work.
- History of chronic neuro-muscular injuries or disorders in the past 6 months.
- Individuals who have received antibiotic treatment or taken probiotic supplements in the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| runningRunning 10 kilometers on a treadmill | Device | Marathon running group |
Primary outcome
Concentration of lactate
Time frame: The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, immediately after exercise, and at 5, 15, 30, and 60 minutes post-exercise.
Measure changes in lactate concentration.
Concentration of creatine kinase
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Measure changes in creatine kinase concentration.
Concentration of glucose
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Measure changes in glucose concentration.
Concentration of creatinine
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Measure changes in creatinine concentration.
Concentration of blood urea nitrogen
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Measure changes in blood urea nitrogen concentration.
Concentration of lactate dehydrogenase
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Measure changes in lactate dehydrogenase concentration.
Concentration of free fatty acid
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Measure changes in free fatty acid concentration.
Concentration of cortisol
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and 60 minutes post-exercise.
Measure changes in cortisol concentration.
ood frequency questionnaire(FFQ)
Time frame: Before exercise
The participants' diets were assessed using a semiquantitative food frequency questionnaire(FFQ). The FFQ used in this study was validated in a previous study; the questionnaire exhibited reliability and validity for identifying major nutrients in the diets of Taiwanese vegetarians and omnivores.(Chiu TH et al., 2014) In this study, the nutrient analysis programme used to calculate the results of the FFQ was based on Taiwan's Food Composition Database. To assess the intake frequency of each food item, frequencies ranged from "never" or "<1 time per month" to "more than 2 times per day.
Gut microbiota analysis
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and at 24 and 48 hours post-exercise.
Collect participant stool samples for gut microbiota analysis.
Untargeted metabolome analysis
Time frame: The testing time points are set as follows: before exercise, immediately after exercise, and at 24 and 48 hours post-exercise.
Collect participant stool samples for metabolome analysis.Metabolite identification aims to analyze the metabolome composition of biological samples, investigate the regulation of metabolic pathways, and explore biochemical mechanisms.
3 secondary outcomes
Body composition
Time frame: Before exercise
Rate of Perceived Exertion(RPE)
Time frame: The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, and immediately after exercise.
Heart rate
Time frame: The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, and immediately after exercise.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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.
Yi-Ju Hsu principal investigator
Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing running in people with Marathon Runner, run by National Taiwan Sport University.
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 3 inclusion and 11 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yi-Ju Hsu (+886-3-328-3201 #2430, ruby780202@ntsu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of lactate (time frame: The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, immediately after exercise, and at 5, 15, 30, and 60 minutes post-exercise.). The study lists 11 primary outcomes in all. 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 1 Nov 2024.