Unique ID issued by UMIN | UMIN000034469 |
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Receipt number | R000039290 |
Scientific Title | A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract -Open Study- |
Date of disclosure of the study information | 2018/10/12 |
Last modified on | 2021/02/17 16:16:38 |
A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract
-Open Study-
A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract
A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract
-Open Study-
A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract
Japan |
No
Adult |
Others
NO
To evaluate the safety of excessive consumption of food containing plant extract
Safety
Doctor's questions, Vital signs, Hematological test, Blood biochemical test, Urinalysis, Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Foods containing plant extract, 4 weeks excessive consumption
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) Healthy males and females aged 20 to 64 years-old whose BMI are under 30.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
(1) Subjects who are under treatment with medications.
(2) Subjects who contract or are undertreatment for serious diseases (e.g., kidney disease, liver disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease).
(3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) during test periods.
(4) Subjects who can't stop drinking from 2 days before each measurement.
(5) Subjects who have declared allergic reaction to ingredients of test foods.
(6) Subjects who have donated over 400mL of blood and/or bood components within the last three months prior to study initiation.
(7) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating.
(8) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(9) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study.
(10) Subjects who are judged as unsuitable for the current study by the investigator or subinvestigators for other reasons.
15
1st name | Yoshitaka |
Middle name | |
Last name | Iwama |
Nihonbashi Cardiology Clinic
Director
103-0001
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
03-5641-4133
yiwama@well-sleep.jp
1st name | Yoshika |
Middle name | |
Last name | Komori |
KSO Corporation
Sales department
105-0023
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshi@kso.co.jp
KSO Corporation
TOYO SHINYAKU Co., Ltd.
Profit organization
Ethical Committee of Kobuna Orthopedics Clinic
311-2 Gokan-machi, Maebashi-shi, Gumma
027-212-5608
sagawa@mc-connect.co.jp
NO
2018 | Year | 10 | Month | 12 | Day |
Unpublished
Completed
2018 | Year | 10 | Month | 04 | Day |
2018 | Year | 10 | Month | 11 | Day |
2018 | Year | 10 | Month | 13 | Day |
2018 | Year | 12 | Month | 11 | Day |
2018 | Year | 10 | Month | 12 | Day |
2021 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039290
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