UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035267 |
|---|---|
| Receipt number | R000040092 |
| Scientific Title | The effect of intake of tea catechins and amino acids on human endurance |
| Date of disclosure of the study information | 2019/11/11 |
| Last modified on | 2022/06/18 09:40:23 |
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Basic information
Public title
The effect of intake of tea catechins and amino acids on human endurance
Acronym
The effect of intake of tea catechins and amino acids on human endurance
Scientific Title
The effect of intake of tea catechins and amino acids on human endurance
Scientific Title:Acronym
The effect of intake of tea catechins and amino acids on human endurance
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of the intake of tea catechins and amino acids on the blood component during exercise and human endurance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Endurance on first and last day of each period (2 weeks)
Key secondary outcomes
Blood component fluctuation, heart rate variability, rate of perceived exertion (RPE), visual analog scale (VAS) for fatigue at exercise test before and after 2 weeks of ingestion of the test article on first and last day of each period (2 weeks)
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of tea catechins and amino acids for 2 weeks and exercise on the first and final day.Washout more than 2 weeks.Intake of placebo (without tea catechins and amino acids) for 2 weeks and exercise on the first and final day.
Interventions/Control_2
Intake of placebo (without tea catechins and amino acids) for 2 weeks and exercise on the first and final day.Washout more than 2 weeks.Intake of tea catechins and amino acids for 2 weeks and exercise on the first and final day.
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1. A person who can express his or her consent in writing about a study participation
2. A person who is healthy men of 20 to 39 years old at the time of obtaining consent.
3. A person who is engaged in exercise training at least three times a week for the competition, etc.
4. A person who can observe compliance rules throughout the exam
Key exclusion criteria
1.The age is not 20 to 39 years old
2. Female
3. Chronic disease patients
4. Heart failure patients and people with a history of myocardial infarction
5. A person who have a history of seizures based on nervous system diseases (loss of consciousness, coma, convulsions, etc.)
6. A person with abnormal sugar / lipid metabolism
7. A person who drinks alcohol (20 g / day or more in terms of alcohol)
8. A person who is taking medication (including supplements)
9. Smoker
10. A person considered to be difficult to exercise due to surgical injuries and medical disorders
11. A person who have lost weight within the past 3 months and those planning to lose weight within the research period
12. A person who plan to become participants in other research within the research period, and those who have already become participants in other research
13. A person who cannot take the test food or drink
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL
+81-4-2947-6774
m.miyashita@waseda.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Miyashita |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL
+81-4-2947-6774
Homepage URL
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
81
Other related organizations
Co-sponsor
Kao Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104, Totsukamachi, Shinjuku-ku, Tokyo
Tel
+81-3-5272-1639
rinri@list.waseda.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
早稲田大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 11 | 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
16
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
| 2018 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040092
