Unique ID issued by UMIN | UMIN000018572 |
---|---|
Receipt number | R000021498 |
Scientific Title | A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H27-0608) |
Date of disclosure of the study information | 2016/03/31 |
Last modified on | 2020/03/31 23:11:42 |
A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H27-0608)
A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract.
A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract. (Ex.no.H27-0608)
A Clinical Study for Evaluating the Safety of Excessive Consumption of Beverages Containing Plant Extract.
Japan |
Healthy Adult
Not applicable | Adult |
Others
NO
To evaluate the safety of excessive consumption of beverage containing plant extract for 4 weeks in healthy adult.
Safety
Medical examination by blood biochemistry, hematology, urinalysis, physical examination at 2-week and 4-week consumption.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
test food containing plant extract
4 weeks excessive consumption.
control food without plant extract
4 weeks excessive consumption.
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) (Healthy) subjects aged 20 to 64 years old.
(2) Subjects giving written informed consent.
(1) Subjects with serious medical history of hepatic, renal, cardiovascular, respiratory and intestinal disease.
(2) Subjects taking any kind of medicine or supplement which affect the result of the trial for habitual use.
(3) Subjects with serious food allergy .
(4) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
30
1st name | Shinichiro |
Middle name | |
Last name | Take |
Saitama Kaisei Hospital
Director
340-0825
455.Daibara.Yashio-city.Saitama
048-995-3331
kaisei-ijika@cure.ocn.ne.jp
1st name | Soichi |
Middle name | |
Last name | Yoneda |
QOL RD Co.,Ltd.
CRO Department Food Division
103-0023
2-14-1,Nihonbashi,Chuo-Ku,Tkyo,
03-6386-8809
s-yoneda@qol-rd.co.jp
QOL RD Co.,Ltd.
Kao Corporation
Profit organization
Saitama Kaisei Hospital IRB
455,Ohara, Yashio
048-995-3331
kaisei-ijika@cure.ocn.ne.jp
NO
埼玉回生病院(埼玉県)、白岡中央総合病院(埼玉県)、横浜なみきリハビリテーション病院(神奈川県)
2016 | Year | 03 | Month | 31 | Day |
Unpublished due to the protocol including the intellectual property rights
Unpublished
works in progress
32
No significant difference in the primary outcome
2020 | Year | 03 | Month | 31 | Day |
Healthy subjects
32 participants completed and 32 subjects were incorporated into the analyses
No adverse effect related to the test diets reported
Safety
Completed
2015 | Year | 07 | Month | 10 | Day |
2015 | Year | 07 | Month | 10 | Day |
2015 | Year | 08 | Month | 07 | Day |
2015 | Year | 10 | Month | 07 | Day |
2015 | Year | 08 | Month | 06 | Day |
2020 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021498