Unique ID issued by UMIN | UMIN000043084 |
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Receipt number | R000049188 |
Scientific Title | A verification study of safety evaluation of excessive ingestion of NMN-containing food in humans: a randomized, double-blind, placebo-controlled, parallel study |
Date of disclosure of the study information | 2021/01/27 |
Last modified on | 2021/06/02 18:53:13 |
A verification study of safety evaluation of excessive ingestion of NMN-containing food in humans: a randomized, double-blind, placebo-controlled, parallel study
Safety evaluation of excess ingestion of NMN-containing food in humans.
A verification study of safety evaluation of excessive ingestion of NMN-containing food in humans: a randomized, double-blind, placebo-controlled, parallel study
Safety evaluation of excess ingestion of NMN-containing food in humans.
Japan |
Healthy adult
Adult |
Others
NO
Safety evaluation of more than five times ingestion of the recommended daily intake of the test food.
Safety
1. Physical examination
2. Urinalysis
3. Blood test
* Assess these tests at screening (before consumption) and at 2 and 4 weeks after consumption and 2 weeks after consumption completed.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of NMN-containing food once a day for 4 weeks.
Intake of placebo without NMN once a day for 4 weeks.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1)Males and females, aged 20 - 65 years old.
2)Subjects who are deagnosed as eligible to participate in the study by the physician
1)A medical history of malignant tumor, heart failure or myocardial infarction.
2) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3) Subjects who currently taking medications (including herbal medicines)
4) Subjects who are allergic to medications and/or the test food related products.
5) Subjects who are pregnant, breast-feeding, or planning to become pregnant.
6) Subjects who are judged as ineligible to participate in the study by the physician.
32
1st name | Atsushi |
Middle name | |
Last name | Yamatsu |
Pharma Foods International Co., Ltd.
Research and Development Department 1
615-8245
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
075-748-9829
a-yamatsu@pharmafoods.co.jp
1st name | Akiko |
Middle name | |
Last name | Ishida |
Pharma Foods International Co., Ltd.
Research and Development Department 2
615-8245
1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
075-748-9829
a-ishida@pharmafoods.co.jp
Pharma Foods International Co., Ltd.
Mitsubishi Corporation Life Sciences Limited
Profit organization
the ethics committees of Yoga Allergy Clinic
4-32-16, Yoga, Setagaya-ku, Tokyo, Japan
03-5491-4478
jim@medipharma.co.jp
NO
2021 | Year | 01 | Month | 27 | Day |
Unpublished
Completed
2020 | Year | 12 | Month | 18 | Day |
2021 | Year | 01 | Month | 15 | Day |
2021 | Year | 01 | Month | 27 | Day |
2021 | Year | 03 | Month | 17 | Day |
2021 | Year | 01 | Month | 21 | Day |
2021 | Year | 06 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049188
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