UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of tea catechins and amino acids on exercise performance in humans
Title of the study (Brief title)	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	Masashi Miyashita
Organization	Tokyo Gakugei University
Division name	Department of Health and Sports Sciences
Address	4-1-1 Nukuikitamachi, Koganei, Tokyo
TEL	0423297622
Email	masashi@u-gakugei.ac.jp

Public contact
Name of contact person	Masashi Miyashita
Organization	Tokyo Gakugei University
Division name	Department of Health and Sports Sciences
Address	4-1-1 Nukuikitamachi, Koganei, Tokyo
TEL	0423297622
Homepage URL
Email	masashi@u-gakugei.ac.jp

Sponsor
Institute	Tokyo Gakugei University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023611