Unique ID issued by UMIN | UMIN000031764 |
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Receipt number | R000036266 |
Scientific Title | A study of safety and effect of miso on blood pressure in subjects with normal to mild hypertension |
Date of disclosure of the study information | 2019/08/07 |
Last modified on | 2020/09/15 09:21:18 |
A study of safety and effect of miso on blood pressure in subjects with normal to mild hypertension
A study of safety and effect of miso on blood pressure
A study of safety and effect of miso on blood pressure in subjects with normal to mild hypertension
A study of safety and effect of miso on blood pressure
Japan |
No
Not applicable | Adult |
Others
NO
To evaluate the safety and effect of miso on blood pressure
Safety,Efficacy
Blood pressure
Interventional
Parallel
Non-randomized
Open -no one is blinded
Placebo
2
Prevention
Food |
2 test food A per day for 8 weeks
2 test food B per day for 8 weeks
40 | years-old | <= |
70 | years-old | > |
Male and Female
(1) Males and females aged 40 to less than 70 years old.
(2) Those who falling under any of the following criteria.
130<=SBP<160 and/or 85<=DBP<100
(1) As a principle, subjects who constantly use oral medication and/or functional foods which may affecting blood pressure.
(2) Subjects having possibilities for emerging allergy related to the study.
(3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required.
(4) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease).
(5) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination.
(6) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire (ex. Subjects who eat miso soup 4 times per week).
(7) Subjects who cannot defend restrictions during the study period.
(8) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study.
(9) Subjects who have a lifestyle affect the result of this study (ex. work on midnight shift) or subjects who are going to change to a lifestyle affect the result of this study.
(10) Subjects who intend to become pregnant or lactating.
(11) Subjects judged as unsuitable for the current study by the investigator.
40
1st name | Seiki |
Middle name | |
Last name | Itou |
Marukome Co.,Ltd
Marketing Department
380-0943
Amori, 883, Nagano-shi, Nagano
080-5147-2676
seiki_itou@marukome.co.jp
1st name | Shingo |
Middle name | |
Last name | Yamamichi |
TTC Co.,Ltd
Clinical Research Planning Department
150-0021
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
s.yamamichi@ttc-tokyo.co.jp
TTC Co.,Ltd
Marukome Co.,Ltd
Profit organization
Aisei Hospital Ueno Clinic Reserch Ethics Committee
2-18-6, Higashiueno, Taitou-ku, Tokyo
03-6455-0880
t.saito@ttc-smo.jp
NO
2019 | Year | 08 | Month | 07 | Day |
Unpublished
Completed
2018 | Year | 03 | Month | 08 | Day |
2018 | Year | 03 | Month | 08 | Day |
2018 | Year | 03 | Month | 19 | Day |
2018 | Year | 08 | Month | 07 | Day |
2018 | Year | 03 | Month | 16 | Day |
2020 | Year | 09 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036266
Research Plan | |
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Research case data specifications | |
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Research case data | |
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