UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060824 |
|---|---|
| Receipt number | R000069559 |
| Scientific Title | Investigation of Anabolic and Catabolic Responses After a Single Bout of Exercise in Healthy Adults: Evaluation Using Urinary 3-Methylhistidine |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/02 19:35:56 |
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Basic information
Public title
Investigation of Anabolic and Catabolic Responses After a Single Bout of Exercise in Healthy Adults
Acronym
Effects of a Single Exercise Session on Muscle Metabolism
Scientific Title
Investigation of Anabolic and Catabolic Responses After a Single Bout of Exercise in Healthy Adults: Evaluation Using Urinary 3-Methylhistidine
Scientific Title:Acronym
Acute Exercise Muscle Metabolism Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to obtain basic knowledge for developing a safe and effective exercise prescription by comparing myokines, free amino acids in the blood, and urinary 3-methylhistidine (3-MH) levels before and after exercise in healthy individuals, with moderate aerobic and resistance exercise as the load conditions and suitable for patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-Methylhistidine in Urine
24-hour urine collection before and after exercise
Key secondary outcomes
Physical characteristics: age, height, weight, gender, exercise habits, skeletal muscle mass
Physical activity (ActiGraph):
Sleep assessment (ActiGraph):
Dietary intake: BDHQ
Blood sampling:
Interleukin-6 (IL-6)
Interleukin-10 (IL-10)
Interleukin-15 (IL-15)
Insulin-like growth factor-1 (IGF-1)
Tumor necrosis factor (TNF)
Brain-derived neurotrophic factor (BDNF)
Blood amino acids
Transthyretin
Retinol-binding protein
Albumin
Serum creatinine
Estimated glomerular filtration rate (eGFR)
Blood urea nitrogen
Creatine kinase
C-reactive protein
Cortisol
Hemoglobin
Hematocrit
Urine collection:
Urinary creatinine
Urinary urea nitrogen
Urinary specific gravity
Blood sampling:
Before exercise, immediately after exercise, 1 hour after exercise, and 24 hours after exercise.
Urine collection:
24-hour urine collection performed before and after the exercise session.
Physical activity and sleep assessment:
Continuous monitoring starting one week prior to the exercise session.
Physical characteristics and dietary intake assessment:
Assessed prior to the exercise session.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Exercise Program Contents
1. Aerobic exercise: 40 minutes on a leg ergometer at 65% of peak VO2.
2. Resistance exercise: Bench press, bent-over row, squat, calf raise, 3 sets of 10 repetitions at 70% of 10RM for each exercise.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 20 or over who are independent in activities of daily living
Key exclusion criteria
Those with neurological symptoms, musculoskeletal diseases, or cardiorespiratory diseases that restrict daily life or work, those suspected of cognitive decline, pregnant women, smokers, those taking medication for lifestyle-related diseases such as hypertension, dyslipidemia, or diabetes, those with autoimmune diseases or chronic inflammatory diseases, those taking steroids/NSAIDs/anti-inflammatory supplements on an ongoing basis, those unable to give consent for the study, and others deemed unsuitable by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kouda |
Organization
Wakayama Medical University
Division name
Department of Rehabilitation Medicine
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama City, Wakayama
TEL
073-441-0666
kenkouda@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Kawasaki |
Organization
Wakayama Medical University Hospital
Division name
Division of Rehabilitation
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama City, Wakayama
TEL
073-441-0666
Homepage URL
shinjik@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069559
