Unique ID issued by UMIN | UMIN000038002 |
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Receipt number | R000043311 |
Scientific Title | Safety evaluation of excessive intake of food containing test foods for healthy adults |
Date of disclosure of the study information | 2019/09/12 |
Last modified on | 2019/11/19 15:07:20 |
Safety evaluation
Safety evaluation
Safety evaluation of excessive intake of food containing test foods for healthy adults
Safety evaluation of excessive intake of food containing test foods
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of ingestion of test foods for 4 weeks
Safety
Physical, Hematologic, Blood biochemical, Urinalysis, Doctor's questions, Weight before and 2,4 weeks after intake and 2 weeks after the end of intake period and Adverse events through the study
Interventional
Parallel
Non-randomized
Open -no one is blinded
Dose comparison
2
Prevention
Food |
Intake of 0.85 g of test food per day for 4 consecutive weeks
Intake of 4.25 g of test food per day for 4 consecutive weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
Males and females from 20 to 64 years of age
(1) Subjects who constantly use health food richly containing involvement ingredient
(2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(4) Who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(5) Subjects having possibilities for emerging allergy related to the study
(6) Those with diseases that require constant medication or a history of serious diseases for which medication was required
(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 | atsushi |
Middle name | |
Last name | higashi |
Shiratori Pharmaceutical Co., Ltd.
Research and Development Dept
275-0016
6-11-24 Tsudanuma, Narashino-city, Chiba-pref
047-453-2500
atsushi-higashi@shiratori-pharm.co.jp
1st name | Yuka |
Middle name | |
Last name | Sato |
TTC Co., Ltd.
Clinical Research Planning Department
150-0021
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
03-5459-5329
y.sato@ttc-tokyo.co.jp
TTC Co., Ltd
Shiratori Pharmaceutical Co., Ltd.
Profit organization
Aisei Hospital Ueno Clinic Research Ethics Committee
2-18-6, Higashiueno, Taitou-ku, Tokyo
03-6455-0880
t.saito@ttc-smo.jp
NO
2019 | Year | 09 | Month | 12 | Day |
Unpublished
Completed
2019 | Year | 08 | Month | 08 | Day |
2019 | Year | 08 | Month | 09 | Day |
2019 | Year | 09 | Month | 13 | Day |
2019 | Year | 11 | Month | 14 | Day |
2019 | Year | 09 | Month | 12 | Day |
2019 | Year | 11 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043311
Research Plan | |
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Research case data specifications | |
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Research case data | |
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