| Unique ID issued by UMIN | UMIN000054328 |
|---|---|
| Receipt number | R000061702 |
| Scientific Title | Verification of the effect of test foods on the intestinal environment |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2024/08/20 09:44:21 |
Verification of the effect of test foods on the intestinal environment
Verification of the effect of test foods on the intestinal environment
Verification of the effect of test foods on the intestinal environment
Verification of the effect of test foods on the intestinal environment
| Japan |
non-handicapped person
| Not applicable | Adult |
Others
NO
We will scientifically evaluate whether the consumption of the test food changes the frequency of defecation and whether it has a secondary relaxing effect by subjective and physiological evaluations.
Efficacy
Frequency of defecation
Visual Analogue Scale
EEG
Autonomic Activity Assessment
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
| Food |
Testfood intake(2weeks) to washout period(2weeks) to Placebo intake(2weeks)
Placebo intake(2weeks) to washout period (2weeks) to Testfood intake(2weeks)
| 18 | years-old | <= |
| 60 | years-old | >= |
Male and Female
1,Japanese national whose native language is Japanese
2,Age at the time of measurement must be between 18 and 60 years old
3,Constipation tendency (average of 3 to 5 bowel movements per week)
However, the defecation status should be checked in the defecation diary at the time of screening, and subjects should be selected
4,BMI 18.5 to 25
1,Those who have a bowel movement every day
2,Those who are receiving treatment (including medication) for some disease at a medical institution
3,Those who have a current or previous serious disease
4,Those who are taking intestinal regulators or laxatives on a daily basis
5,Those who routinely consume food for specified health use, functional foods, yogurt, or lactic acid bacteria beverages that are thought to be involved in intestinal regulation
6,Those who habitually take supplements or nutrient-fortified foods on a daily basis
7,Those who have drug allergy or food allergy or have a history of such allergy (Those who are at risk of developing allergic symptoms to the test food)
8,Those who have participated or are currently participating in other clinical trials within 1 month of obtaining consent, or those who plan to participate during the study period
9,Those who have an irregular rhythm of life, such as shift work, late-night work, etc.
10,Those who drink a lot of alcohol on a daily basis (alcohol equivalent to 60g/day)
11,Smoking
12,Patients who are judged to be inappropriate for this study by the investigator
13,BMI less than 18.5 or greater than 25
10
| 1st name | Kenjirou |
| Middle name | |
| Last name | Hara |
Fuji Nihon Seito Corporation
Functional Food Sales Department
424-0924
1-4-10 Sheikai Shimizu-ku Shizuoka City Shizuoka Ken
054-334-5357
kenjirou.hara@fnsugar.co.jp
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Faculty of Agriculture Graduate school of Kyushu University
Laboratory of Systematic Forest and Forest Products Science
819-0395
744 Motooka,Nishiku-Fukuoka,Fukuoka,Japan
0928024675
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Fuji Nihon Seito Corporation
Kenjirou Hara
Fuji Nihon Seito Corporation
Profit organization
Shiba Palace Clinic Ethics Review Committee
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
0354081590
shiba_palace@s-palace-clinic.com
NO
| 2024 | Year | 05 | Month | 07 | Day |
Unpublished
Completed
| 2024 | Year | 03 | Month | 14 | Day |
| 2024 | Year | 03 | Month | 14 | Day |
| 2024 | Year | 05 | Month | 07 | Day |
| 2024 | Year | 09 | Month | 30 | Day |
| 2024 | Year | 05 | Month | 07 | Day |
| 2024 | Year | 08 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061702