UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A preliminary genome-wide association study of plasma catechin concentration in Japanese individuals after ingestion of green tea catechins
Title of the study (Brief title)	A preliminary GWAS of plasma catechin concentration in Japanese individuals after ingestion of green tea catechins
Region	Japan

Condition
Condition	Healthy Japanese adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to investigate the causes of individual differences in plasma catechin concentrations by using a preliminary genome-wide association study of green tea catechin concentration in the plasma after ingestion. First, we examine the plasma catechin concentrations in healthy Japanese individuals. The subjects ingested 1 g of green tea catechins in a fasting state, and their plasma catechin concentration are measured 1 h after ingestion. The subjects are defined in terms of their plasma catechin concentration as follows: hyper-responders and hypo-responders. Second, we conduct a preliminary genome-wide association study of common variants associated with plasma catechin concentration 1 h after ingestion in those responders.
Basic objectives2	Others
Basic objectives -Others	SNPs associated with plasma catechin concentration after 1 hour ingestion of catechins.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	SNPs associated with plasma catechin concentration after 1 hour ingestion of catechins
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	Single oral dose of 1 g of green tea catechins in a fasting state
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subjects are competent to consent, keep the rules of the study. 2) We measure plasma catechin concentration in subjects 1 h after ingestion of catechins. The subjects are defined in terms of their plasma catechin concentration as follows: hyper-responders (plasma catechin concentration is more than upper flexion point) and hypo-responders (plasma catechin concentration is less than lower flexion point).
Key exclusion criteria	1) Anemia 2) Subjects who are inadequate for enrollment judged by the investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	Yuko Sagesaka, PhD
Organization	ITO EN, Ltd.
Division name	Central Research Institute
Address	21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL	0548-54-1247
Email	y-sagesaka@itoen.co.jp

Public contact
Name of contact person	Makoto Kobayashi, PhD
Organization	ITO EN, Ltd.
Division name	Central Research Institute
Address	21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL	0548-54-1247
Homepage URL
Email	m-kobayasi@itoen.co.jp

Sponsor
Institute	Central Research Institute, ITO EN, Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Genequest Inc.
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	（株）伊藤園中央研究所（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 06 Day
Anticipated trial start date	2015 Year 09 Month 11 Day
Last follow-up date	2016 Year 03 Month 01 Day
Date of closure to data entry	2016 Year 04 Month 08 Day
Date trial data considered complete	2016 Year 05 Month 10 Day
Date analysis concluded	2016 Year 08 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 27 Day
Last modified on	2016 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028303