Unique ID issued by UMIN | UMIN000022649 |
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Receipt number | R000026113 |
Scientific Title | The safety evaluation of excessive intake of Saccharomyces cerevisiae SM-10 in healthy adults |
Date of disclosure of the study information | 2016/06/07 |
Last modified on | 2016/11/08 15:46:57 |
The safety evaluation of excessive intake of Saccharomyces cerevisiae SM-10 in healthy adults
Safety evaluation of excessive intake of Saccharomyces cerevisiae SM-10
The safety evaluation of excessive intake of Saccharomyces cerevisiae SM-10 in healthy adults
Safety evaluation of excessive intake of Saccharomyces cerevisiae SM-10
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of excessive intake of SM-10 supplements for 4 weeks.
Safety
Confirmatory
Pragmatic
Hematologic test
Blood biochemistry test
Urine test
Blood pressure/pulsation
Weight/body mass index
Medical Interview
Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
SM-10 supplements are ingested for 4 consecutive weeks at 3,000 mg.
20 | years-old | <= |
64 | years-old | >= |
Female
Healthy males and females at the ages of 20 to 64
1. Subjects who routinely use health food containing S-adenosyl methionine
2. Subjects having a current or past history of serious diseases such as diabetes, hepatic or renal disorder, or cardiovascular disease
3. Subjects having possibilities for emerging allergy related to the study
4. Subjects having possibilities for emerging allergy related to the study
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 within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study
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 who are judged as unsuitable for this study by physician
10
1st name | |
Middle name | |
Last name | hiroyuki kimura |
Horus Co., Ltd.
Academic Planning Department
3-3-5 Nakano Nakano-ku Tokyo
03-5328-9331
kimura.hiroyuki@horus-jnl.co.jp
1st name | |
Middle name | |
Last name | hiroko onoda, tomohiro utsue, sayuri fujita |
Horus Co., Ltd.
Academic Planning Department
3-3-5 Nakano Nakano-ku Tokyo
03-5328-9331
http://horus-jnl.com/
gakujutu.mail@horus-jnl.co.jp
TTC CO., LTD.
Horus Co., Ltd.
Profit organization
NO
2016 | Year | 06 | Month | 07 | Day |
Unpublished
Completed
2016 | Year | 05 | Month | 26 | Day |
2016 | Year | 06 | Month | 08 | Day |
2016 | Year | 06 | Month | 07 | Day |
2016 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026113
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