Unique ID issued by UMIN | UMIN000043698 |
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Receipt number | R000049895 |
Scientific Title | A verification study of safety evaluation of excessive consumption of the test food: an open-label trial |
Date of disclosure of the study information | 2021/03/22 |
Last modified on | 2021/10/18 09:48:34 |
A verification study of safety evaluation of excessive consumption of the test food
A verification study of safety evaluation of excessive consumption of the test food
A verification study of safety evaluation of excessive consumption of the test food: an open-label trial
A verification study of safety evaluation of excessive consumption of the test food
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To identify the safety of overdose the test food (five times more than regular daily intake) for four weeks in healthy Japanese subjects
Safety
Confirmatory
Pragmatic
Not applicable
1. Incidence of side effects
2. 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 intervention)
2. Physical measurement
3. Urinalysis
4. Blood test
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Duration: Four weeks
Test food: Capsules containing 10-hydroxy-cis-12-octadecenoic acid (HYA)
Administration: Take three capsules (HYA 500 mg/capsule) three times per day before each meal with water.
*If you forget to take the test food, take it as soon as you remember within the day
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects whose BMI are 23 kg/m2 or more and less than 30 kg/m2 at screening
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 who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
5. Subjects who 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 could have allergic to gelatin
8. Subjects who are judged as ineligible to participate in the study based on their responses to the lifestyle questionnaire
9. Subjects who are pregnant, lactation, or planning to become pregnant
10. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
11. Subjects who are judged as ineligible to participate in the 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.
Noster Inc.
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 | 03 | Month | 22 | Day |
Unpublished
11
Completed
2021 | Year | 03 | Month | 17 | Day |
2021 | Year | 03 | Month | 17 | Day |
2021 | Year | 03 | Month | 23 | Day |
2021 | Year | 08 | Month | 21 | Day |
2021 | Year | 03 | Month | 22 | Day |
2021 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049895
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