Unique ID issued by UMIN | UMIN000026083 |
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Receipt number | R000029975 |
Scientific Title | Safety evaluation study of long-term intake beef cooked with soy sauce containing Salacia extract in adult men and women. |
Date of disclosure of the study information | 2018/02/13 |
Last modified on | 2018/10/24 09:19:27 |
Safety evaluation study of long-term intake beef cooked with soy sauce containing Salacia extract in adult men and women.
Safety evaluation study of long-term intake of food containing plant extract in adult men and women.
Safety evaluation study of long-term intake beef cooked with soy sauce containing Salacia extract in adult men and women.
Safety evaluation study of long-term intake of food containing plant extract in adult men and women.
Japan |
Healthy adult
Adult |
Others
NO
To evaluate safety of intake of food containing plant extract for 12 weeks
Safety
Incidence of side effect
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of test food for 12 weeks, everyday
Intake of placebo food for 12 weeks, everyday
20 | years-old | <= |
64 | years-old | >= |
Male and Female
1.Healthy subjects aged from 20 to 64 years-old at the time of giving informed consent
2.Subjects whose fasting blood glucose is less than or equal to 125mg/dl at the time of giving informed consent
3.Subjects having no dietary restriction
4.Subjects neither attending the hospital as outpatients nor medicated
5.Subjects without serious liver disorder, renal disturbance, heart disease, cerebrovascular disease, organ derangement and allergic disease.
6.Subjects who fully understand and agree with the objective of this study by prior oral explanation and are able to give informed consent written by themselves
1.Subjects having allergies for drugs and foods
2.Subjects who drink alcohol more than in terms of 500ml beer in a day.
3.Subjects who smoke more than 20 cigarettes on average in a day
4.Pregnant women, or women intending to be pregnant, and lactating women
5.Subjects who donated more than 200ml of blood within 1 month or more than 400ml of blood within 3 months prior to the study
6.Subjects who are participating in the other clinical trial
7.Subjects who don't follow the instructions from the doctor or the staff
30
1st name | |
Middle name | |
Last name | Kazuhiko Fujisawa |
Ageokousei Hospital
Director
421-1 , Jitoukata, Ageo-shi, Saitama
048-781-1101
susumu.hosonuma@achs.jp
1st name | |
Middle name | |
Last name | Hitomi Nasu |
QOL RD Co.,Ltd.
CRO Department Food Division
2-14-1, Nihonbashi, Chuo-Ku, Tokyo, Japan
03-6386-8809
h-nasu@qol-rd.co.jp
QOL RD Co.,Ltd.
Yoshinoya holdings
Profit organization
NO
2018 | Year | 02 | Month | 13 | Day |
Published
http://www.toukastress.jp/webj/month/2017
Completed
2016 | Year | 12 | Month | 15 | Day |
2017 | Year | 02 | Month | 13 | Day |
2017 | Year | 02 | Month | 10 | Day |
2018 | Year | 10 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029975
Research Plan | |
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