Unique ID issued by UMIN | UMIN000048784 |
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Receipt number | R000055582 |
Scientific Title | A study to evaluate the safety of long-term consumption of the test food in human: an open-label trial |
Date of disclosure of the study information | 2024/01/25 |
Last modified on | 2023/04/13 13:00:55 |
A study to evaluate the safety of long-term consumption of the test food in human
A study to evaluate the safety of long-term consumption of the test food in human
A study to evaluate the safety of long-term consumption of the test food in human: an open-label trial
A study to evaluate the safety of long-term consumption of the test food in human
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the safety of consumption of the test food for 12 weeks in human
Safety
Confirmatory
Pragmatic
Not applicable
1. Incidence of adverse events
1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption; Scr)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Duration: 12 weeks
Test food: METABOLAID(R)
Administration: Take two capsules with water without chewing once a day.
*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 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 pregnant, lactating, or planning to become pregnant during this trial
8. Subjects who suffer from COVID-19
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
10
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.
Willfarm 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)
2024 | Year | 01 | Month | 25 | Day |
Unpublished
11
Completed
2022 | Year | 08 | Month | 24 | Day |
2022 | Year | 08 | Month | 24 | Day |
2022 | Year | 08 | Month | 29 | Day |
2023 | Year | 01 | Month | 26 | Day |
2022 | Year | 08 | Month | 29 | Day |
2023 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055582
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