Unique ID issued by UMIN | UMIN000051047 |
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Receipt number | R000058201 |
Scientific Title | A verification study of the reduction effect of the test food consumption on blood pressure: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/05/12 |
Last modified on | 2024/04/19 11:14:27 |
A verification study of the reduction effect of the test food consumption on blood pressure
A verification study of the reduction effect of the test food consumption on blood pressure
A verification study of the reduction effect of the test food consumption on blood pressure: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A verification study of the reduction effect of the test food consumption on blood pressure
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the reduction effect of the test food consumption for 12 weeks on blood pressure
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured value of systolic blood pressure at 12 weeks after consumption (12w)
1. The amount of changes from screening (before test-food consumption; Scr) in systolic blood pressure at 12w
2. The measured value of systolic blood pressure at four and eight weeks after consumption (4w and 8w), and the amount of changes from Scr
3. The measured values of diastolic blood pressure at 4w, 8w, and 12w, and the amount of changes from Scr
4. The subjects who have 129 mmHg or less of systolic blood pressure and 89 mmHg or less of diastolic blood pressure at 12w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Treatment
Food |
Duration: 12 weeks
Test food: Active tablet
Administration: Take one tablet with water before every meals. In total three tablets a day, taken three times daily.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks
Test food: Placebo tablet
Administration: Take one tablet with water before every meals. In total three tablets a day, taken three times daily.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects who are between 130 mmHg or more and 139 mmHg or less in systolic blood pressure at screening (before test-food consumption; Scr)
6. Subjects who are no more than 89 mmHg in diastolic blood pressure at Scr
7. Subjects who are judged as eligible to participate in the study by the physician
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are a smoker
8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in this study by the physician
60
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Toyo Sugar Refining Co., Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2023 | Year | 05 | Month | 12 | Day |
Unpublished
68
Completed
2023 | Year | 04 | Month | 19 | Day |
2023 | Year | 04 | Month | 19 | Day |
2023 | Year | 05 | Month | 12 | Day |
2023 | Year | 11 | Month | 20 | Day |
2023 | Year | 05 | Month | 12 | Day |
2024 | Year | 04 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058201
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