UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018469
Receipt No. R000021388
Scientific Title Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of Yabukita green tea and Sun Rouge green tea on the Improvement of Blood Pressure and Eyestrain
Date of disclosure of the study information 2015/07/29
Last modified on 2016/07/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of Yabukita green tea and Sun Rouge green tea on the Improvement of Blood Pressure and Eyestrain
Acronym The Effect of Daily Ingestion of the green tea on the improvement of Blood Pressure and Eyestrain
Scientific Title Double-Blind, Placebo-Controlled Study for the Effect of Daily Ingestion of Yabukita green tea and Sun Rouge green tea on the Improvement of Blood Pressure and Eyestrain
Scientific Title:Acronym The Effect of Daily Ingestion of the green tea on the improvement of Blood Pressure and Eyestrain
Region
Japan

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

Objectives
Narrative objectives1 To prove the clinical usefulness of daily ingestion of Yabukita green tea or Sun Rouge green tea for 12 weeks on blood pressure and eyestrain improvement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes systolic blood pressure and diastolic blood pressure (hospital blood pressure and home blood pressure), focus-adjustment function
Key secondary outcomes VAS questionnaire for eyestrain symptoms, intraocular pressure, peripheral blood flow, MDA-LDL,TBARS,SOD,8-OHdG, hs-CRP,adiponectin, ADMA, blood RNA related to functional expression of the green tea-component, total homocysteine, LDL-C

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of Yabukita green tea daily for 12 weeks
Interventions/Control_2 Ingestion of Sun Rouge green tea daily for 12 weeks
Interventions/Control_3 Ingestion of barley tea for 12 weeks
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
60 years-old >
Gender Male and Female
Key inclusion criteria Subjects whose blood pressure meet either of the following criteria
1. Hospital SBP is 130 mmHg or more and less than 160 mmHg and DBP is less than 100 mmHg
2. Hospital DBP 80 mmHg or more and less than 100 mmHg and SBP is less than 160 mmHg
3. Home SBP is 125 mmHg or more and less than 155 mmHg and DBP is less than 95 mmHg
4. Home DBP is 75 mmHg or more and less than 95 mmHg and SBP is less than 155mmHg

Subjects who agree to participate in the current study with a written informed consent
Key exclusion criteria 1. Subjects who are under treatment and medication for hypertension
2. Subjects who are under treatment and medication for ocular disease (except for myopia, astigmatism, hyperopia, presbyopia, dry eye, and allergc conjunctival disease) or with serious ocular diseases.
3. Subjects who have a major ophthalmic surgical history such as cataract, glaucoma, refractive correction
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities
5. Subjects who have a major surgical history related to digestive system such as gastrectomy
6. Subjects with unusually high and/or low blood pressure or abnormal hematological data
7. Subjects with serious anemia
8. Pre- or post-menopausal subjects having complaints of obvious physical changes
9. Subjects who are at risk of having allergic reactions to drugs or foods (especially green tea)
10. Subjects who has high caffeine sensitivity
11. Subjects regularly take medicine, functional foods and/or supplements ( peptide, acetic acid, GABA, geniposidic acid, flavonoids, sesamin, chlorella, olive leaves, garlics, dietary fiber, tomatoes, folic acid, etc.) which would affect the blood pressure
12. Subjects regularly take medicine, functional foods and/or supplements (anthocyanin, lutein, astaxanthin, blueberry, beta-carotene, vitamin, DHA, EPA etc.) which would affect the visual fatigue
13. Heavy smokers, alcohol addicts or subjects with irregular lifestyle
14. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study
15. Subjects who are pregnant or expected to be pregnant, or lactating during the study
16. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial
17. Any other medical reasons judged by the principal investigator
Target sample size 108

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Center of Health Information Science
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor National Food Research Institute,
National Agriculture and Food Research Organization
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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 29 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 06 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 29 Day
Last follow-up date
2015 Year 12 Month 02 Day
Date of closure to data entry
2016 Year 01 Month 14 Day
Date trial data considered complete
2016 Year 01 Month 21 Day
Date analysis concluded
2016 Year 02 Month 29 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2016 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021388

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.