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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024592
Receipt No. R000028303
Scientific Title A preliminary genome-wide association study of plasma catechin concentration in Japanese individuals after ingestion of green tea catechins
Date of disclosure of the study information 2016/10/27
Last modified on 2016/10/27

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Basic information
Public title A preliminary genome-wide association study of plasma catechin concentration in Japanese individuals after ingestion of green tea catechins
Acronym A preliminary GWAS of plasma catechin concentration in Japanese individuals after ingestion of green tea catechins
Scientific Title A preliminary genome-wide association study of plasma catechin concentration in Japanese individuals after ingestion of green tea catechins
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuko Sagesaka, PhD
Organization ITO EN, Ltd.
Division name Central Research Institute
Zip code
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
1st name
Middle name
Last name Makoto Kobayashi, PhD
Organization ITO EN, Ltd.
Division name Central Research Institute
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2015 Year 08 Month 06 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028303

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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