UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063345 |
|---|---|
| Receipt number | R000072505 |
| Scientific Title | The Investigation involved in Regulation of Skeletal Muscle Apolipoproteins by Exercise and Its Physiological Mechanisms |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/19 18:28:18 |
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Basic information
Public title
Elucidation of the Mechanism by Which Exercise Alters Lipid-Transport Proteins in Muscles
Acronym
Exercise and the Mechanism of Lipid Transport in Muscles
Scientific Title
The Investigation involved in Regulation of Skeletal Muscle Apolipoproteins by Exercise and Its Physiological Mechanisms
Scientific Title:Acronym
Exercise Response of Skeletal Muscle Apolipoproteins
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Medicine in general | Cardiology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to elucidate the physiological mechanisms through the regulation of skeletal muscle apolipoproteins by exercise in healthy individuals. This will be achieved through comprehensive analyses, that include the study of gene and protein expression, proteomics, transcriptomics, and their integrated analysis, using blood and skeletal muscle (muscle biopsy) samples collected before and after exercise.
Basic objectives2
Others
Basic objectives -Others
To elucidate the physiological mechanisms through the regulation of skeletal muscle apolipoproteins by exercise.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of skeletal muscle apolipoprotein A1 mRNA expression levels before and after exercise intervention
Key secondary outcomes
Changes in skeletal muscle mRNA, proteins, and histopathology (including markers related to lipid metabolism, glucose metabolism, and stem cells); elucidation of the regulatory and physiological mechanisms of apolipoprotein A1/C2 induced by moderate-intensity exercise through a comprehensive analysis; identification of RNA sequence variations in skeletal muscle apolipoproteins (ApoA1 and ApoC2) using RACE (Rapid Amplification of cDNA Ends); changes in autonomic nervous system activity and blood parameters (lipid metabolism-related markers, glucose metabolism-related markers, fatty acid-related markers, metabolites, myokines) induced by moderate-intensity exercise; changes in body composition and anthropometric measurements (height, weight, and body fat percentage); and shifts in responses to health-related questionnaires.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Moderate-intensity exercise (Exercise load schedule: 3 days per week for 4 weeks, for a total of 12 sessions [1 session: 30 minutes of continuous moderate-intensity exercise on a cycle ergometer])
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Individuals who have received a thorough explanation of the purpose and content of this study, possess the capacity to give informed consent, have volunteered of their own free will after fully understanding the study, and are able to provide written consent to participate.
2. Healthy men between the ages of 18 and 40.
3. Individuals who do not engage in at least 20 hours of physical training per week.
Key exclusion criteria
1. Individuals with serious or progressive underlying medical conditions or symptoms, such as ischemic heart disease or neuromuscular disorders, whom the principal investigator determines cannot be ensured safety if they participate in the study.
2. Individuals who regularly take medications that affect metabolism (such as diabetes medications, lipid-lowering medications, alpha-blockers, beta-blockers, diuretics, anticoagulants).
3. Individuals who regularly consume excessive amounts of alcohol (60 g or more of pure alcohol per day) or smoke cigarettes.
4. Individuals who regularly consume large amounts of supplements (protein and amino acid-based products)(40 g or more per day).
5. Individuals with a cardiac pacemaker or an implantable cardioverter-defibrillator (ICD)
6. Individuals whom the principal investigator deems unsuitable as a study participant
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Uehara |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
8-19-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
092-871-6631
ueharay@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinari |
| Middle name | |
| Last name | Uehara |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
8-19-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
092-871-6631
Homepage URL
ueharay@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Bioethics and Medical Ethics, Fukuoka University School of Medicine
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-u.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 | 11 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | 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 | 10 | Month | 19 | Day |
Last modified on
| 2026 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072505
