Unique ID issued by UMIN | UMIN000045342 |
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Receipt number | R000051779 |
Scientific Title | Effects of consumption of the test food on the swelling in health Japanese sucjects: An open-label trial |
Date of disclosure of the study information | 2021/09/01 |
Last modified on | 2021/09/24 18:29:39 |
Effects of consumption of the test food on the swelling in health Japanese sucjects
Effects of consumption of the test food on the swelling in health Japanese sucjects
Effects of consumption of the test food on the swelling in health Japanese sucjects: An open-label trial
Effects of consumption of the test food on the swelling in health Japanese sucjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the reduction effect of swelling with consumption of the test food.
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured value of the swelling volume of the lower leg*1 at two weeks after consumption (2w)
*1It is calculated by subtracting the lower leg volume in the morning from that in the evening
1. The measured value at 2w of the following items: the lower leg volume in the morning or evening, the facial swelling volume*2, subjective symptoms of swollen legs or face (visual analogue scale), and calf circumference (maximum circumference of the lower leg)
*2It is calculated by subtracting the face volume in the morning from that in the evening
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
1
Treatment
Food |
Duration: Two weeks
Test food: Powdered beverage containing polyphenols
Administration: Dissolve one packet with water and drink after lunch
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
* Subjects should take test food after lunch even in each test.
20 | years-old | <= |
Not applicable |
Female
1. Japanese
2. Women
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects who concerns about swollen legs
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects whose swelling volume of the lower leg are large at Scr
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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hypotension, hemorrhagic disease, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage 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 pregnant, breast-feeding, and planning to become pregnant
8. 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
9. Subjects who have surgery within the last 14 days before the agreement to participate in this trial or plan of surgery during the consumption
10. Subjects who are judged as ineligible to participate in the study by the physician
4
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.
Meiji Food Materia 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)
2021 | Year | 09 | Month | 01 | Day |
Unpublished
4
No longer recruiting
2021 | Year | 08 | Month | 25 | Day |
2021 | Year | 08 | Month | 25 | Day |
2021 | Year | 09 | Month | 02 | Day |
2021 | Year | 10 | Month | 23 | Day |
2021 | Year | 09 | Month | 01 | Day |
2021 | Year | 09 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051779
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