Unique ID issued by UMIN | UMIN000027857 |
---|---|
Receipt number | R000031918 |
Scientific Title | Assessment of safety and effective dose of a food thought to improve the intestinal environment. |
Date of disclosure of the study information | 2017/06/21 |
Last modified on | 2018/01/02 13:24:39 |
Assessment of safety and effective dose of a food thought to improve the intestinal environment.
Safety of a food thought to improve the intestinal environment.
Assessment of safety and effective dose of a food thought to improve the intestinal environment.
Safety of a food thought to improve the intestinal environment.
Japan |
Healthy volunteers
Adult |
Others
NO
The purpose of this study is to evaluate the safety of daily intake of a food thought to improve the intestinal environment and determine the effective dose.
Safety
Hematologic test
Blood biochemistry test
Interview with a doctor
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
4
Prevention
Food |
Male subjects, who take 1 stick of a food thought to improve the intestinal environment daily for 3 months.
Female subjects, who take 1 stick of a food thought to improve the intestinal environment daily for 3 months.
Male subjects, who take 2 sticks of a food thought to improve the intestinal environment daily for 3 months.
Female subjects, who take 2 sticks of a food thought to improve the intestinal environment daily for 3 months.
20 | years-old | <= |
75 | years-old | > |
Male and Female
1. Those who can understand the purpose and contents of this study and agree by letter to participate.
2. Those who have been diagnosed with a tendency to constipation after responding to a questionnaire.
1. Pregnant women, breast feeding mothers
2. Those who are taking medication for a disease of the digestive organs (including constipation symptoms), that affects gastrointestinal function.
3. Those who have a disease.
4. Those who have an allergy to fruit.
60
1st name | |
Middle name | |
Last name | Prof. Shunji Mizobuchi |
Kochi Medical School, Kochi University
Clinical nursing
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
088-866-5811
mizoshun@kochi-u.ac.jp
1st name | |
Middle name | |
Last name | Shunji Mizobuchi |
Kochi Medical School, Kochi University
Clinical nursing
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
088-880-2564
mizoshun@kochi-u.ac.jp
Kochi University
Public Interest Incorporated Foundation
KOCHI INDUSTRIAL PROMOTION CENTER
Other
Japan
Umajimura agricultural cooperative
MUSE Co.,Ltd.
NO
高知大学医学部(高知県)、高知大学医学部附属病院(高知県)、医療法人 仁泉会 朝倉病院(高知県)、馬路村立馬路診療所(高知県)
2017 | Year | 06 | Month | 21 | Day |
Unpublished
Completed
2017 | Year | 05 | Month | 22 | Day |
2017 | Year | 06 | Month | 21 | Day |
2017 | Year | 11 | Month | 17 | Day |
2017 | Year | 11 | Month | 17 | Day |
2017 | Year | 06 | Month | 21 | Day |
2018 | Year | 01 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031918