UMIN-CTR Clinical Trial

Basic information
Public title	An open label study of the elevation of plasma catechin concentration
Acronym	An open label study of the elevation of plasma catechin concentration
Scientific Title	An open label study of the elevation of plasma catechin concentration
Scientific Title:Acronym	An open label study of the elevation of plasma catechin concentration
Region	Japan

Condition
Condition	Healthy Japanese adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To investigate the causes of individual differences in plasma catechin concentrations by using a preliminary genome-wide association study
Basic objectives2	Others
Basic objectives -Others	SNPs associated with plasma catechin concentration after ingestion of catechins.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma catechin concentration
Key secondary outcomes	SNPs associated with plasma catechin concentration

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	Single oral dose 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. Subjects who are judged by the physician as eligible to participate in the trial
Key exclusion criteria	. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactating, or intending to become pregnan 8. Subjects who participated in other clinical tests in 3 months before a consent form acquisition day or who are planning to participate in the test duration 9. Subjects who are judged by the physician as ineligible to participate in the trial
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Kobayashi
Organization	ITO EN, Ltd.
Division name	Central Research Institute
Zip code	421-0516
Address	21 Mekami, Makinohara-shi, Shizuoka, Japan
TEL	0548-54-1247
Email	m-kobayasi@itoen.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Kobayashi
Organization	ITO EN, Ltd
Division name	Central Research Institute
Zip code	421-0516
Address	21 Mekami, Makinohara-shi, Shizuoka, 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	Central Research Institute, ITO EN, Ltd
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical review committee
Address	3-47-10 Honmachi, shibuya-ku, Tokyo
Tel	03-5371-7195
Email	k-murayama@itoen.co.jp

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	医療法人社団盛心会タカラクリニック

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 03 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	Delay expected
Results Delay Reason	Recruiting and conducting has been suspended by communicable disease (COVID-19)in Japan
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	Suspended
Date of protocol fixation	2020 Year 01 Month 21 Day
Date of IRB	2019 Year 09 Month 09 Day
Anticipated trial start date	2020 Year 02 Month 01 Day
Last follow-up date	2020 Year 03 Month 14 Day
Date of closure to data entry	2020 Year 03 Month 14 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 04 Month 01 Day
Last modified on	2020 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045628

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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