Unique ID issued by UMIN | UMIN000044352 |
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Receipt number | R000050653 |
Scientific Title | A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients.(SME-2021-01-FOSHUS) |
Date of disclosure of the study information | 2021/05/27 |
Last modified on | 2022/08/22 13:37:51 |
A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients. ( SME-2021-01-FOSHUS)
A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients.
A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients.(SME-2021-01-FOSHUS)
A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients.
Japan |
Not applicable
Not applicable | Adult |
Others
NO
To evaluate the blood pressure lowering effect when adult men and women are ingested food containing plant-derived ingredients.
Efficacy
Systolic blood pressure / Diastolic blood pressure
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Daily intake of test food for 12 weeks
Daily intake of control food for 12 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) Males and females who are -> 20 years old at the time of IC acquisition and <65 years old at the end of the study.
(2) Those who can visit to destination medical institution on the scheduled date.
(3) Those who have submitted written informed consent after fully understanding the purpose and content of this study.
(1) Those who heavy use of alcohol or smoke
(2) Those who continuously ingest foods for specified health use, foods with functional claims, health foods, and foods that may affect blood pressure evaluation.
(3) Those who continuously take medicines or quasi-drugs
(4) Those who are participating in other study or planning to participate or participated within the past 4 weeks.
(5) Those who are:
a) heart, liver, or kidney disease (including complications of other diseases)
b) having a history of cardiovascular disease
c) diabetes
d) allergic to test foods
e) with systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher
f) with a BMI of 30 or higher
g) having a history or respiratory illness (excluding childhood asthma)
(6) Others who are judged inappropriate for participant by the investigator
120
1st name | Takao |
Middle name | |
Last name | Tanaka |
SUNTORY MONOZUKURI EXPERT LIMITED
HE Center
135-8631
2-3-3 Daiba, Minato-ku, Tokyo, Japan
03-5579-1277
Takao_Tanaka@suntory.co.jp
1st name | Noriko |
Middle name | |
Last name | Sekiguchi |
SUNTORY MONOZUKURI EXPERT LIMITED
HE Center
135-8631
2-3-3 Daiba, Minato-ku, Tokyo, Japan
03-5579-1277
N_Sekiguchi@suntory.co.jp
SUNTORY MONOZUKURI EXPERT LIMITED
Suntory Beverage & Food Limited
Profit organization
NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
06-4797-5660
jimukyoku@amc-clinc.jp
NO
2021 | Year | 05 | Month | 27 | Day |
Published
120
Completed
2021 | Year | 05 | Month | 27 | Day |
2021 | Year | 05 | Month | 27 | Day |
2021 | Year | 05 | Month | 28 | Day |
2021 | Year | 11 | Month | 05 | Day |
2021 | Year | 05 | Month | 27 | Day |
2022 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050653
Research Plan | |
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Research case data specifications | |
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