UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044265 |
|---|---|
| Receipt number | R000050549 |
| Scientific Title | Effect of amino acid-containing foods on exercise performance and condition in competitive swimmer |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/06/26 13:48:57 |
* 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
Effect of amino acid-containing foods on exercise performance and condition in competitive swimmer
Acronym
Effect of amino acid-containing foods on exercise performance and condition in competitive swimmer
Scientific Title
Effect of amino acid-containing foods on exercise performance and condition in competitive swimmer
Scientific Title:Acronym
Effect of amino acid-containing foods on exercise performance and condition in competitive swimmer
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effect of amino acid- containing foods on exercise performance and condition in competitive swimmer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Swimming time
Key secondary outcomes
Rate of perceived exertion
Blood lactate concentration
Lactate metabolic rate
Heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Amino acid(4.5 g, 1 time, 4.0 g as an amino acid)
Interventions/Control_2
Placebo(4.5 g, 1 time)
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Males and females aged 18 years or higher,and less than 30 years.
2.Individuals who belong to swimming club in Nihon University.
3.Individuals who receive a sufficient explanations with regard to the objective and details of the study, and fully understood and agree to voluntarily provide a written informed consent
Key exclusion criteria
1. Individuals who have difficulty in exercising due to surgical or medical disorders.
2. Individuals who are participating in other studies or have participated in a study within 2 weeks retrospectively from other long term study.
3. Individuals who received more than 200 ml of blood collection within 12 weeks from the study.
4. Individuals who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ueno |
Organization
Nihon University
Division name
College of sports sciences
Zip code
154-0002
Address
3-34-1, shimouma, setagaya-ku, Tokyo
TEL
03-6453-1776
ueno.kouji@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ueno |
Organization
Nihon University
Division name
College of sports sciences
Zip code
154-0002
Address
3-34-1, shimouma, setagaya-ku, Tokyo
TEL
03-6453-1776
Homepage URL
ueno.kouji@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
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
Ethical Committee of Nihon University
Address
3-34-1, shimouma, setagaya-ku, Tokyo
Tel
03-6453-1700
rmss.kenkyu@nihon-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
日本大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | 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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 05 | Month | 19 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050549
