UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052256 |
|---|---|
| Receipt number | R000059624 |
| 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) |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2024/09/18 14:59:07 |
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Basic information
Public title
Basic research on nutritional status, metabolism and physiological functions during exercise (Basic research on muscle synthesis and damage)
Acronym
Basic research on muscle synthesis and damage
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)
Scientific Title:Acronym
Basic research on non-invasive evaluation of muscle synthesis and damage associated with increased physical activity
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
(Daytime and nighttime on non-exercise day, daytime (including exercise) and nighttime (recovery period) on exercise day)
Key secondary outcomes
Urinary excretion: creatinine, 3-methylhistidine, catecholamine, C-peptide immunoreactivity
(Daytime and nighttime on non-exercise day, daytime (including exercise) and nighttime (recovery period) 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
Day 1 dinner at 18:00, complete urination at 19:00 (start of urine collection)
Day 2 end of nighttime urine collection at 7:00, breakfast at 8:00, lunch at 12:30, dinner at 18:00, end of daytime urine collection at 19:00
Day 3 end of nighttime urine collection at 7:00, breakfast at 8:00, exercise from 9:30 (walking 6 km/hour for 90 min), lunch at 12:30, exercise from 14:00 (walking 6 km/hour for 90 min), dinner at 18:00, end of daytime urine collection at 19:00
Day 4 end of nighttime urine collection at 7:00
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 ages 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
Tetsuo Yamada
Funding Source
Organization
Kanto Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
関東学院大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 20 | 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
| Delay expected |
Results Delay Reason
Because the study is currently underway.
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
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059624
