Unique ID issued by UMIN | UMIN000024575 |
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Receipt number | R000028280 |
Scientific Title | A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure. |
Date of disclosure of the study information | 2016/10/27 |
Last modified on | 2017/06/15 14:22:36 |
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.
Effects of Daily Ingestion Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study of Effects of Daily Ingestion of Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.
Effects of Daily Ingestion Shiikuwasha (Citrus depressa Hayata) Juice on Blood Pressure.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To prove clinical benefits associated with daily shiikuwasha juice ingestion for 8 weeks on blood pressure and also to investigate the potential health benefits of shiikuwasha juice including improvement in lipid and glucose metabolism.
Efficacy
Pragmatic
Not applicable
Systolic and diastolic blood pressure at 4 and 8 weeks after ingestion of test meals.
TC, LDL-C, HDL-C, TG, fasting plasma glucose, HbA1c, body weight, BMI, body fat percentage.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Food |
Daily ingestion of 95 ml of shiikuwasha juice for 8 weeks.
Daily ingestion of 95 ml of placebo beverage for 8 weeks.
30 | years-old | <= |
70 | years-old | > |
Male and Female
1. Subjects whose SBP in a clinic is >=130 mmHg and <160 mmHg.
2. Subjects who agree to participate in this study with a written informed consent.
1. Subjects who are under physician's advice, treatment and/or medication for hypertension.
2. Subjects who have (or suspected) secondary hypertension such as chronic glomerulonephritis, pyelonephritis, primary aldosteronism, phaeochromocytoma, Cushing's syndrome, hyperthyroidism, etc.
3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
4. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
5. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
6. Subjects with severe anemia.
7. Pre- or post-menopausal women complaining obvious physical changes.
8. Subjects who are at risk of having allergic reactions to drugs or foods (especially citrus fruits).
9. 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, long pepper extract, etc.) which potentially affect the blood pressure.
10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
11. Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study.
12. Pregnant or lactating women or women expect to be pregnant during this study.
13. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study.
14. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
40
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
Health Information Science Center
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Clock Work Inc.
Profit organization
Japan
NO
北海道情報大学 保健センター(北海道)
2016 | Year | 10 | Month | 27 | Day |
Unpublished
Completed
2016 | Year | 09 | Month | 29 | Day |
2016 | Year | 10 | Month | 28 | Day |
2017 | Year | 01 | Month | 23 | Day |
2017 | Year | 02 | Month | 06 | Day |
2017 | Year | 02 | Month | 13 | Day |
2017 | Year | 03 | Month | 31 | Day |
2016 | Year | 10 | Month | 26 | Day |
2017 | Year | 06 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028280
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