NCT06670742

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

October 26, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

November 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 26, 2024

Last Update Submit

October 31, 2024

Conditions

Outcome Measures

Primary Outcomes (11)

  • Concentration of lactate

    Measure changes in lactate concentration.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Before exercise

  • Gut microbiota analysis

    Collect participant stool samples for gut microbiota analysis.

    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.

    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

    Before exercise

  • Rate of Perceived Exertion(RPE)

    The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, and immediately after exercise.

  • Heart rate

    The testing time points are set as follows: before exercise, at the 5-kilometer mark during exercise, and immediately after exercise.

Study Arms (2)

Marathon running group

EXPERIMENTAL

Run 10 kilometers on a treadmill.

Device: running

General healthy adult group

NO INTERVENTION

No intervention will be conducted.

Interventions

runningDEVICE

Running 10 kilometers on a treadmill

Marathon running group

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Generally healthy, untrained individuals.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yi-Ju Hsu

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 26, 2024

First Posted

November 1, 2024

Study Start

November 8, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 1, 2024

Record last verified: 2024-10