UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020477 |
|---|---|
| Receipt number | R000023611 |
| Scientific Title | The effect of tea catechins and amino acids on exercise performance in humans |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2017/07/11 12:09:56 |
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Basic information
Public title
The effect of tea catechins and amino acids on exercise performance in humans
Acronym
Catechins plus amino acids and exercise performance
Scientific Title
The effect of tea catechins and amino acids on exercise performance in humans
Scientific Title:Acronym
Catechins plus amino acids and exercise performance
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of tea catechins and amino acids intakes on exercise performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Yo-Yo intermittent recovery test (level 2)distance
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
1)Yo-Yo intermittent recovery test (level 2)
2)Tea catechins beverage (500ml/day) intake for 14 days
3) Yo-Yo intermittent recovery test(level 2) performing 15 min after amino acid jelly drink intake (130g x 2)
4) 14 days washout
5) Placebo beverage (500ml/day) intake for 14 days
6) Yo-Yo intermittent recovery test (level 2) performing 15 min after placebo jelly drink (130g x 2) intake
Interventions/Control_2
1) Yo-Yo intermittent recovery test (level 2)
2) Placebo beverage (500ml/day) intake for 14 days
3) Yo-Yo intermittent recovery test (level 2) performing 15 min after placebo jelly drink (130g x 2) intake
4) 14 days washout
5) Tea catechins beverage (500ml/day) intake for 14 days
6) Yo-Yo intermittent recovery test (level 2) performing 15 min after amino acid jelly drink (130g x 2) intake
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
A male university student who perform exercise five times a week
Key exclusion criteria
A person who has surgical injury and chronic disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Miyashita |
Organization
Tokyo Gakugei University
Division name
Department of Health and Sports Sciences
Zip code
Address
4-1-1 Nukuikitamachi, Koganei, Tokyo
TEL
0423297622
masashi@u-gakugei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Miyashita |
Organization
Tokyo Gakugei University
Division name
Department of Health and Sports Sciences
Zip code
Address
4-1-1 Nukuikitamachi, Koganei, Tokyo
TEL
0423297622
Homepage URL
masashi@u-gakugei.ac.jp
Sponsor or person
Institute
Tokyo Gakugei University
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Corporation
Kao Corporation
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
Address
Tel
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
| 2016 | Year | 01 | Month | 07 | 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
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 07 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
