UMIN-CTR Clinical Trial

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

Healthy male adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Waseda University

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

81

Co-sponsor

Kao Corporation

Name of secondary funder(s)

Organization

Waseda University

Address

1-104, Totsukamachi, Shinjuku-ku, Tokyo

Tel

+81-3-5272-1639

Email

rinri@list.waseda.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

早稲田大学（埼玉県）

Date of disclosure of the study information

2019

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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