Unique ID issued by UMIN | UMIN000022501 |
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Receipt number | R000025938 |
Scientific Title | Safety evaluation studies of excessive consumption of supplements in adult men and women |
Date of disclosure of the study information | 2016/05/30 |
Last modified on | 2016/11/25 18:54:43 |
Safety evaluation studies of excessive consumption of supplements in adult men and women
Safety evaluation studies of excessive consumption of supplements in adult men and women
Safety evaluation studies of excessive consumption of supplements in adult men and women
Safety evaluation studies of excessive consumption of supplements in adult men and women
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of excessive consumption of supplements, 5-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
QOL questionnaire
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Ingestion of the test supplement for 4 weeks
20 | years-old | <= |
79 | years-old | >= |
Male and Female
Healthy adult males and females from 20 to 79 years of age
(1) Subjects who routinely use health food richly containing active ingredients
(2) Subjects having a disease requiring regular medication, a brain disorder, or a history of serious diseases for which medication was required
(3) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(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 are judged as unsuitable for the study based on the results of lifestyle questionnaire
(7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(8) Subjects who intend to become pregnant or lactating
(9) Subjects judged as unsuitable for the study by the investigator for other reasons
20
1st name | |
Middle name | |
Last name | Tetsuya Hirata |
KOBAYASHI Pharmaceutical Co.,Ltd
R&D Healthcare Division
1-30-3, Toyokawa, Ibaraki-city, Osaka567-0057, JAPAN
072-640-0131
t.hirata@kobayashi.co.jp
1st name | |
Middle name | |
Last name | Etsushi Yamamoto |
TTC Co.,Ltd.
Clinical Research Planning Department
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
e.yamamoto@ttc-tokyo.co.jp
TTC Co.,Ltd
KOBAYASHI Pharmaceutical Co.,Ltd
Profit organization
NO
2016 | Year | 05 | Month | 30 | Day |
Unpublished
Completed
2016 | Year | 05 | Month | 26 | Day |
2016 | Year | 05 | Month | 31 | Day |
2016 | Year | 05 | Month | 27 | Day |
2016 | Year | 11 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025938
Research Plan | |
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Research case data specifications | |
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Registered date | File name |
Research case data | |
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