Unique ID issued by UMIN | UMIN000020186 |
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Receipt number | R000023312 |
Scientific Title | Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study. |
Date of disclosure of the study information | 2015/12/15 |
Last modified on | 2017/06/15 11:11:59 |
Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Effect of prune concentrate on blood pressure in subjects with high-normal blood pressure or grade I hypertension: a pilot study.
Japan |
Healthy volunteers
Hypertension
Cardiology | Adult |
Others
NO
The purpose of this study is to evaluate the effect of prune concentrate on blood pressure.
Efficacy
Exploratory
Not applicable
Systolic blood pressure and diastolic blood pressure at baseline, 6 and 12 weeks.
FMD (flow mediated dilation), NOx, ADMA (asymmetric dimethylarginine), platelet aggregation test, thromboxane B2, urinary 8-isoprostane, MDA (malondialdehyde), urinary 8-OHdG (8-hydroxydeoxyguanosine), BAP (biological antioxident potential) test, high-sensitivity CRP, and intestinal flora (T-RFLP), at baseline and 12 weeks.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
NO
Central registration
2
Prevention
Food |
Subjects receive 18 g of prune concentrate 3 times per day for 12 weeks.
Subjects receive 18 g of placebo 3 times per day for 12 weeks.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
High-normal blood pressure or grade I hypertension
1) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia
2) Taking drugs or functional food that may affect the trial
3) Participation in any clinical trial within 90 days of the commencement of the trial
4) Fruit allergy
5) In pregnancy or nursing a child
6) Cardiac, renal, and/or hepatic dysfunction
7) History of severe disease and/or major surgery
20
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Hiroshima University, Institute of Biomedical & Health Sciences
Project Research Center for Clinical Trial and Preventive Medicine
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
082-257-1533
fumiko@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Hiroshima University, Institute of Biomedical & Health Sciences
Project Research Center for Clinical Trial and Preventive Medicine
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
082-257-1533
fumiko@hiroshima-u.ac.jp
Hiroshima University
MIKI Corporation
Profit organization
NO
広島大学病院(広島県)
2015 | Year | 12 | Month | 15 | Day |
Unpublished
Completed
2015 | Year | 11 | Month | 27 | Day |
2016 | Year | 02 | Month | 01 | Day |
2015 | Year | 12 | Month | 14 | Day |
2017 | Year | 06 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023312
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