UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055588 |
|---|---|
| Receipt number | R000063464 |
| Scientific Title | Basic research on nutritional status, metabolism and physiological functions during exercise (Basic research on non-invasive evaluation of muscle synthesis and damage associated with increased physical activity (2)) |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2025/09/28 16:05:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Basic research on nutritional status, metabolism and physiological functions during exercise (Basic research on muscle synthesis and damage (2))
Acronym
Basic research on muscle synthesis and damage (2)
Scientific Title
Basic research on nutritional status, metabolism and physiological functions during exercise (Basic research on non-invasive evaluation of muscle synthesis and damage associated with increased physical activity (2))
Scientific Title:Acronym
Basic research on non-invasive evaluation of muscle synthesis and damage associated with increased physical activity (2)
Region
| Japan |
Condition
Condition
Healthy Person (Adult)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain basic data for "non-invasive evaluation of muscle synthesis and damage associated with increased physical activity" by measuring the urinary levels of insulin-like growth factor 1 (IGF-1) and human titin N fragment
Basic objectives2
Others
Basic objectives -Others
To examine the degree of change in urinary levels of IGF-1 and human titin N fragment associated with exercise
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Urinary excretion: IGF-1, human titin N fragment
(Early morning and evening on non-exercise day, early morning and evening on exercise day)
Key secondary outcomes
Urinary excretion: creatinine, urea nitrogen, catecholamine, C-peptide immunoreactivity
(Early morning and evening on non-exercise day, early morning and evening on exercise day)
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
| Behavior,custom |
Interventions/Control_1
1. Schedule
The day before: Dinner at 18:00
Day 1 (non-exercise day): Urine collection from 6:00 to 8:00, breakfast at 8:00, lunch at 12:00, urine collection from 16:00 to 18:00, dinner at 18:00
Day 2 (exercise day): Urine collection from 6:00 to 8:00, breakfast at 8:00, exercise from 10:00, lunch at 12:00, urine collection from 16:00 to 18:00, dinner at 18:00
Next day: Urine collection from 6:00 to 8:00
2. Experimental diet
Energy intake is 2,000 to 2,400 kcal/day (for subjects weighing around 50 to 60 kg), and the amount of each nutrient is to meet the recommended dietary allowance or adequate intake level in the "Dietary Reference Intakes for Japanese".
3. Exercise load
Exercise form is a bicycle ergometer, the amount of exercise is equivalent to 20% of the energy intake (400-480 kcal (for subjects weighing around 50-60 kg)), and the intensity of exercise is 60-70% of the maximum oxygen intake.
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 and Female
Key inclusion criteria
Healthy male or female between the age of 18 to 40
Key exclusion criteria
if abnormal findings are found in the medical examination
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Yamada |
Organization
Kanto Gakuin University
Division name
Department of Nutrition and Dietetics, College of Nutrition
Zip code
236-8503
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
TEL
045-786-7221
tyyamada@kanto-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Yamada |
Organization
Kanto Gakuin University
Division name
Department of Nutrition and Dietetics, College of Nutrition
Zip code
236-8503
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
TEL
045-786-7221
Homepage URL
tyyamada@kanto-gakuin.ac.jp
Sponsor or person
Institute
Kanto Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kanto Gakuin 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
Kanto Gakuin University
Address
1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Japan
Tel
045-786-2924
kenkyu@kanto-gakuin.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
| 2024 | Year | 09 | Month | 24 | 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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 09 | Month | 23 | Day |
Last modified on
| 2025 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063464
