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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000040022
Receipt No. R000045628
Scientific Title An open label study of the elevation of plasma catechin concentration
Date of disclosure of the study information 2020/04/03
Last modified on 2020/04/01

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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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