Unique ID issued by UMIN | UMIN000018469 |
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Receipt number | 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 13:31:29 |
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
The Effect of Daily Ingestion of the green tea on the improvement of Blood Pressure and Eyestrain
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
The Effect of Daily Ingestion of the green tea on the improvement of Blood Pressure and Eyestrain
Japan |
Healthy adults
Adult |
Others
YES
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.
Efficacy
Pragmatic
Not applicable
systolic blood pressure and diastolic blood pressure (hospital blood pressure and home blood pressure), focus-adjustment function
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
YES
No need to know
3
Treatment
Food |
Ingestion of Yabukita green tea daily for 12 weeks
Ingestion of Sun Rouge green tea daily for 12 weeks
Ingestion of barley tea for 12 weeks
20 | years-old | <= |
60 | years-old | > |
Male and Female
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
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
108
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Center of Health Information Science
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Ministry of Agriculture, Forestry and Fisheries
Japanese Governmental office
National Food Research Institute,
National Agriculture and Food Research Organization
NO
北海道情報大学 保健センター(北海道)
2015 | Year | 07 | Month | 29 | Day |
Unpublished
Completed
2015 | Year | 06 | Month | 22 | Day |
2015 | Year | 07 | Month | 29 | Day |
2015 | Year | 12 | Month | 02 | Day |
2016 | Year | 01 | Month | 14 | Day |
2016 | Year | 01 | Month | 21 | Day |
2016 | Year | 02 | Month | 29 | Day |
2015 | Year | 07 | Month | 29 | Day |
2016 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021388
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