UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024592 |
|---|---|
| Receipt number | 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 16:12:03 |
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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
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
m-kobayasi@itoen.co.jp
Sponsor or person
Institute
Central Research Institute, ITO EN, Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028303
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