UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052868 |
|---|---|
| Receipt number | R000060316 |
| Scientific Title | The investigation study on endogenous amino acids and amino acid derivatives responses to sprint and endurance exercise trials. |
| Date of disclosure of the study information | 2023/11/22 |
| Last modified on | 2024/03/25 09:21:31 |
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Basic information
Public title
The investigation study on endogenous amino acids and amino acid derivatives changes following exercise.
Acronym
The investigation study on endogenous amino acids and amino acid derivatives changes following exercise.
Scientific Title
The investigation study on endogenous amino acids and amino acid derivatives responses to sprint and endurance exercise trials.
Scientific Title:Acronym
The investigation study on endogenous amino acids and amino acid derivatives responses to sprint and endurance exercise trials.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to elucidate the responses of blood amino acids in healthy males aged 20 to under 65 following exercise trials.
Basic objectives2
Others
Basic objectives -Others
Metabolic responses to exercise
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(Metabolic responses to exercise)
1. Amino acids
2. Lactate
3. Amino acid derivatives
* Examine time-course metabolomic changes in blood before and after exercise trials (0,60,120,180 min)
* For the endurance exercise trial, blood collection will take place before exercise, 30 minutes during the exercise, and at 0, 60, 120, and 180 min after exercise.
Key secondary outcomes
1.Physical measurement
2.Vital signs(Blood pressure/heart rate)
*During endurance exercise trial, real time heart rate is monitored for maintaining 60% heart reserve rate.
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
Exercise trials
The sprint exercise trial in this study involves a warm-up (5 minutes, 1.5 kg m, 50 W), exercise load (30 seconds, 3.0 kg m), and cool-down (5 minutes, 1.5 kg m, 50 W). After the cool-down, the exercise load is repeated, followed by a final cool-down (2 minutes, 1.5 kg m, 50 W) to conclude the exercise.
For the endurance exercise trial, participants will maintain 60% of their heart rate reserve for 60 minutes. The evaluation method involves measuring endogenous amino acids and their metabolites as well as lactate in blood.
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1. Age at the time of obtaining written consent is 20 years or older but less than 65 years for males.
2. Individuals who, after receiving sufficient explanation of the purpose and content of the study, possess the capacity to consent, understand well, and voluntarily express their willingness to participate in the trial by providing written consent.
Key exclusion criteria
1.Individuals currently undergoing medication or outpatient treatment for any serious illness.
2.Individuals currently undergoing exercise or dietary therapy under medical supervision.
3. Individuals with current or past history of substance dependence or alcohol dependence.
4.Individuals currently undergoing outpatient treatment for mental disorders (such as depression) or sleep disorders, or with a history of past mental health disorders.
5.Individuals with irregular lifestyle rhythms due to night shifts or shift work.
6.Individuals with extremely irregular habits in diet, sleep, and other lifestyle factors.
7.Individuals practicing extreme dietary restrictions.
8.Individuals with a history of or current serious diseases, such as brain disorders, malignant tumors, immune disorders, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, thyroid disorders, adrenal disorders, and other serious metabolic disorders.
9. Individuals regularly consuming supplements containing GABA.
10.Individuals who have participated in another clinical trial (study) within the past 3 months from the date of consent or have plans to participate in another clinical trial (study) during the trial period.
11. Individuals who have donated blood or blood components exceeding 200 mL within the past 1 month or 400 mL within the past 3 months from the date of consent.
12. Individuals who find it difficult to comply with the recording requirements of various survey forms.
13. Any other individuals deemed unsuitable as participants by the trial coordinator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kim |
| Middle name | |
| Last name | Youngil |
Organization
Pharma Foods International,Co.Ltd.
Division name
Research and Development
Zip code
615-8245
Address
1-49, Goryo-Ohara, Nishikyo-ku, Kyoto city, Kyoto, Japan
TEL
075-748-9829
youngil-kim@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Arif |
| Middle name | Yanuar |
| Last name | Ridwan |
Organization
Pharma Foods International,Co.Ltd.
Division name
Research and Development
Zip code
615-8245
Address
1-49, Goryo-Ohara, Nishikyo-ku, Kyoto city, Kyoto, Japan
TEL
075-748-9829
Homepage URL
arif@pharmafoods.co.jp
Sponsor or person
Institute
Pharma Foods International,Co.Ltd.
Institute
Department
Personal name
Funding Source
Organization
Pharma Foods International,Co.Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Pharma Foods International
Address
1-49, Goryo-Ohara, Nishikyo-ku, Kyoto city, Kyoto, Japan
Tel
075-394-8605
m-yoshida@pharmafoods.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
株式会社ファーマフーズ(京都府)/Pharma Foods International Co., Ltd. (Kyoto)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 22 | 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
10
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
| 2023 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 22 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060316
