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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035267
Receipt No. 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 2020/06/16

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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
Email 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
Email m.miyashita@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

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
Email 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
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
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
2020 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040092

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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