UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049398 |
|---|---|
| Receipt number | R000056249 |
| Scientific Title | An exploratory study of the relationship between physical conditions and urinary metabolite profiles in athletes |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2023/06/15 09:25:16 |
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Basic information
Public title
An exploratory study of the relationship between physical conditions and urinary metabolite profiles in athletes
Acronym
An exploratory study of the relationship between physical conditions and urinary metabolite profiles in athletes
Scientific Title
An exploratory study of the relationship between physical conditions and urinary metabolite profiles in athletes
Scientific Title:Acronym
An exploratory study of the relationship between physical conditions and urinary metabolite profiles in athletes
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the possibility of constructing diagnostic techniques using urinary metabolites.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the relationship between exercise-induced changes in physical conditions and urinary metabolites.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Urine test (amino acid, cartilage status, micronutrients, urine specific gravity, creatinine, pH)
-Blood test (amino acids, muscle damage, inflammation, immunity, oxidative stress, energy status, nutritional status)
-Saliva test (immunity)
-Performance test (lower limbs power)
-Range of motion test (knee range of motions)
Key secondary outcomes
VAS (physical pain and fatigue)
RPE (Borg Scale)
Exercise load information
Daily information
Background information
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male
Key inclusion criteria
1) Athletes belonging to sports club of university
2) Healthy male
3) Individuals aged 18 or higher
4) Individuals who can make self-judgment and voluntarily provides written informed consent.
Key exclusion criteria
1) Individual who cannot complete due to injury or any other reasons.
2) Individuals who received more than 200 mL of blood withdrawal within 12 weeks
3) Individuals who are going to participate other studies during this study
4) Individuals who have disease and are receiving drug treatment.
5) Individuals who have history of hepatic, kidney, heart, lung and cardiovascular disorder
6) Individuals who are assessed to be inappropriate by the principal medical doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirohisa |
| Middle name | |
| Last name | Uchida |
Organization
Ajinomoto Co., Inc.
Division name
Sports Nutrition Department
Zip code
104-8315
Address
15-1, Kyobashi 1-chome, Chuo-ku, Tokyo, Japan
TEL
080-2289-1646
hirohisa.uchida.vg3@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kuroyanagi |
Organization
EUPHORIA Co., Ltd.
Division name
Sports data management division
Zip code
102-0085
Address
Iidabiru2F 5-5 Rokubancho, Chiyoda-ku, Tokyo, Japan
TEL
050-1746-4393
Homepage URL
hiroki.kuroyanagi@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co.,Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6205-6222
suda-clinic_irb@imeq.co.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 | 12 | Month | 31 | 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
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of the relationship between exercise-induced changes in physical conditions and urinary metabolites.
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056249
