Unique ID issued by UMIN | UMIN000041294 |
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Receipt number | R000047157 |
Scientific Title | A verification study of safety evaluation of excessive the test food consumption in humans: A randomized double-blind placebo-controlled trial |
Date of disclosure of the study information | 2020/08/03 |
Last modified on | 2021/02/08 15:18:26 |
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive the test food consumption in humans: A randomized double-blind placebo-controlled trial
A verification study of safety evaluation of excessive the test food consumption in humans
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the safety of consuming five times the daily intake for four weeks in healthy Japanese subjects.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. Incidence of side effects
2. Incidence of adverse events
1. Physical examination
2. Urinalysis
3. Blood test
4. Original questionnaires
5. The measured values of the total score of self-administered dementia checklist (SDC), and the score of cognitive function and life function at two and four weeks after the start of test-food consumption
6. The change of the total score of SDC, and the score of cognitive function and life function at two and four weeks after the start of test-food consumption
7. The measured value of BDNF at four weeks after the start of test-food consumption
8. The change of BDNF at four weeks after the start of test-food consumption
9. The measured values of all of the total score of SDC at two and four weeks after the start of test-food consumption
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Prevention
Food |
Duration: Four weeks
Test food: Capsule containing lipid-soluble polyphenol
Administration: Take five capsules per day after breakfast with water.
*If you forget to take the test food, take it as soon as you remember within the day.
Duration: Four weeks
Test food: Placebo
Administration: Take five capsules per day after breakfast 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. Healthy Japanese adult subjects
2. 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. 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 use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
5. Subjects currently regularly 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 three months before the agreement to participate in this trial or plan to participate another trial during this trial
9. Subjects who are judged as ineligible to participate in the study by the physician
20
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
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.
Satsuma Shuzo 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)
2020 | Year | 08 | Month | 03 | Day |
Unpublished
22
Completed
2020 | Year | 07 | Month | 27 | Day |
2020 | Year | 07 | Month | 27 | Day |
2020 | Year | 08 | Month | 04 | Day |
2020 | Year | 12 | Month | 19 | Day |
2020 | Year | 08 | Month | 03 | Day |
2021 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047157
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