UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045864 |
|---|---|
| Receipt number | R000052354 |
| Scientific Title | Investigation for recovery of fatigue by ingestion of Amazake in Futsal player, randomized cross-over study |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2023/11/20 12:44:40 |
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Basic information
Public title
The effects of Amazake ingestion on recovery of fatigue in Futsal player
Acronym
Effects of Amazake ingestion on recovery of fatigue in athletes
Scientific Title
Investigation for recovery of fatigue by ingestion of Amazake in Futsal player, randomized cross-over study
Scientific Title:Acronym
Recovery of fatigue by ingestion of Amazake
Region
| Japan |
Condition
Condition
Healthy athletes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of Amazake ingestion on recovery from fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum and saliva hormone after the ingestion for 3 weeks
Key secondary outcomes
Subjective fatigue
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Ingestion of test drink for 3 weeks/ washout period for 2 weeks/ Ingestion of placebo drink for 3 weeks
Interventions/Control_2
Ingestion of placebo drink for 3 weeks/ washout period for 2 weeks/ Ingestion of test drink for 3 weeks
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
| Not applicable |
Gender
Male
Key inclusion criteria
Professional or semiprofessional Futsal player
Key exclusion criteria
Can not drink Amazake
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Ishikawa-Takata |
Organization
Tokyo University of Agriculture
Division name
Faculty of Applied Bioscience
Zip code
1568502
Address
1-1-1 Sakuragaoka, Setagaya Tokyo,Japan
TEL
81-3-5477-2453
kt207460@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Ishikawa-Takata |
Organization
Tokyo University of Agriculture
Division name
Faculty of Applied Bioscience
Zip code
1568502
Address
1-1-1 Sakuragaoka, Setagaya Tokyo,Japan
TEL
81-3-5477-2453
Homepage URL
kt207460@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Agriculture
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
Tokyo University of Agriculture, The Ethical Committee of Experiment and Survey for Human
Address
1-1-1 Sakuragaoka, Setagaya Tokyo,Japan
Tel
81-3-5477-2532
t3tanaka@nodai.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
| 2021 | Year | 10 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052354
