Unique ID issued by UMIN | UMIN000042950 |
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Receipt number | R000049031 |
Scientific Title | Study to evaluate the safety of overconsumption of test food |
Date of disclosure of the study information | 2021/01/17 |
Last modified on | 2021/04/15 14:57:21 |
Study to evaluate the safety of overconsumption of test food
Study to evaluate the safety of overconsumption of test food
Study to evaluate the safety of overconsumption of test food
Study to evaluate the safety of overconsumption of test food
Japan |
Healthy adults
Adult |
Others
NO
To evaluate the safety of test food by ingesting 5 times the defined amount for 4 weeks in healthy men and women aged between 20 and 64.
Safety
Incidence of side effects and adverse events
General hematology / blood biochemistry tests, urinalysis, physiotherapy, vital signs
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Take 10 tablets of test food with water after breakfast
20 | years-old | <= |
64 | years-old | > |
Male and Female
1. Aged between 20 and 64 years at the time of informed consent
2. Japanese male or female
3. Participant who can input electronic diary with smartphone/PC
4. Participant who can provide written consent
1. using medication or Chinese medication (except for the drugs as needed)
2. on diet / exercise therapy under the guidance of a doctor
3. history or current episode of serious diseases such as heart failure, myocardial infarction
4. history of gastrointestinal surgery (except for appendicitis)
5. taking healthy food or supplements daily
6. allergic for some drugs or food
7. participation in another clinical trial in the previous one month, currently, or during the trial.
8. pregnant or lactating, or willing to be pregnant during the trial
9. Alcohol consumption of >60g equivalent
10. heavy smoker (21 or more cigarettes /day)
11. on irregular diet, working in shift or late at night
12. donate component blood or 200ml of whole blood in the previous one month before the trial, or planning to donate blood during the trial
13. donate 400ml of whole blood in the previous three months before the trial
14. judged by the investigator to be unsuitable for participating in this study
12
1st name | Naoki |
Middle name | |
Last name | Igari |
Daiwa Pharmaceutical Co., Ltd.
Research and Development Department
154-0024
1-16-19 Sangenjaya Setagaya-ku Tokyo
03-5430-4050
igari@daiwa-pharm.com
1st name | Hirokuni |
Middle name | |
Last name | Kayama |
IMEQRD Co., Ltd
Sales department
104-0061
6-2-1 Ginza Chuo-ku Tokyo
03-6704-5968
h-kayama@imeqrd.co.jp
IMEQRD Co., Ltd
Daiwa Pharmaceutical Co., Ltd.
Profit organization
Suda Clinic institutional review board
2-8-14,Takadanobaba,Shinjyuku,Tokyo
03-6704-5968
n-yuzawa@imeqrd.co.jp
NO
2021 | Year | 01 | Month | 17 | Day |
Unpublished
Completed
2020 | Year | 12 | Month | 04 | Day |
2020 | Year | 12 | Month | 22 | Day |
2021 | Year | 01 | Month | 18 | Day |
2021 | Year | 03 | Month | 17 | Day |
2021 | Year | 01 | Month | 08 | Day |
2021 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049031
Research Plan | |
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Research case data specifications | |
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Research case data | |
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