Unique ID issued by UMIN | UMIN000027093 |
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Receipt number | R000031055 |
Scientific Title | Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women |
Date of disclosure of the study information | 2017/04/21 |
Last modified on | 2017/10/07 10:45:24 |
Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of excessive consumption of Watanabe Oyster DHMBA Jelly, 3-fold quantity of recommended daily intake.
Safety
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/ body mass index
Doctor's questions
Adverse event
Evaluate at points of 2-week and 4-week of consumption and 2 weeks after the end of consumption period.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Ingestion of the test product for 4 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
Healthy adult males and females from 20 to 64 years of age
(1) Subjects who routinely use health food richly containing DHMBA or oyster meat extract
(2) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(3) Subjects having possibilities for emerging allergy related to the study
(4) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(6) Subjects who have participated in other clinical studies
(7) Subjects who intend to become pregnant or lactating
(8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(9) Subjects judged as unsuitable for the study by the investigator for other reasons
11
1st name | |
Middle name | |
Last name | Emiko Miki |
Watanabe Oyster Laboratory, Co., Ltd.
Scientific Department
490-3, Shimoongata-Cho, Hachioji-City, Tokyo
042-651-8118
gakujutsu@oyster.co.jp
1st name | |
Middle name | |
Last name | Hiroyasu Shimada |
TTC Co., Ltd.
Clinical Research Planning Department
1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
h.shimada@ttc-tokyo.co.jp
TTC Co., Ltd.
Watanabe Oyster Laboratory, Co., Ltd.
Profit organization
NO
2017 | Year | 04 | Month | 21 | Day |
Unpublished
Completed
2017 | Year | 04 | Month | 13 | Day |
2017 | Year | 04 | Month | 22 | Day |
2017 | Year | 04 | Month | 21 | Day |
2017 | Year | 10 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031055
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