Unique ID issued by UMIN | UMIN000035881 |
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Receipt number | R000040881 |
Scientific Title | Effect of the test food on breath hydrogen excretion -A randomized, open-label, cross over study- |
Date of disclosure of the study information | 2019/02/15 |
Last modified on | 2019/08/19 09:23:47 |
Effect of the test food on breath hydrogen excretion
-A randomized, open-label, cross over study-
Effect of the test food on breath hydrogen excretion
Effect of the test food on breath hydrogen excretion
-A randomized, open-label, cross over study-
Effect of the test food on breath hydrogen excretion
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To investigate the effect of the test food on breath hydrogen excretion
Efficacy
Breath hydrogen excretion(AUC 0-8h)
Breath hydrogen excretion(The observed values and the change from pre-intake of breath hydrogen excretion at each evaluation point)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Placebo
No need to know
2
Prevention
Food |
Single intake of test food- single intake of control food
Single intake of control food- single intake of test food
20 | years-old | <= |
65 | years-old | > |
Male and Female
1)Male and Female aged from 20 to 65 years old at the time of informed consent is taken
2)Subjects whose BMI below 25 at the screening test
3)Subjects who eat 3 times a day
4)Subjects who agree to participate in the study on one's own will
1)Subjects who are suffering from disease affect gastric emptying and digestion function
2)Subjects who have a surgical history of the digestive organs
3)Subjects who have a disease such as upper respiratory inflammation and acute gastroenteritis
4)Subjects who defecate 3 times or above per day
5)Subjects who defecate less than 3 times per week
6)Subjects who are suffering from indigestion symptoms
7)Subjects who have a habit of excessive alcohol
8)Subjects who smoke daily
9)Subjects who had taken antibiotics and/or anti-microbe a gents within 1 month prior to date of the informed consent, or who is going to taking them during study
10)Subjects who taking medicine that may affect the examination and subjects who eat daily brown rice, cereals etc
11)Subjects who take health food (a probiotic dairy product etc) excessively that may affect the examination
12)Subjects who is allergic to rice
13)Subjects who are pregnant or breast-feeding, or subjects who expect to be pregnant during this study
14)Subjects who participating in other clinical studies, or who are planning to participate in other clinical studies during the present study
15)Subjects whose fasting breath methane concentration is 10 ppm or above at the screening test
16)Subjects who are judged as unsuitable for the study by the investigator for other reasons
20
1st name | Kei |
Middle name | |
Last name | Yui |
FANCL Corporation
Research Institute, Health science research center
244-0806
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
045-820-3755
ke-yui@fancl.co.jp
1st name | Eiji |
Middle name | |
Last name | Yoshikawa |
KSO Corporation
Sales department
105-0023
Shibaura Omodaka Building7F, 1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
FANCL Corporation
Profit organization
Ethical Committee of Nihonbashi Cardiology Clinic
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
03-5641-4133
niho-jimucho@well-sleep.jp
NO
日本橋循環器科クリニック(東京都) Nihonbashi Cardiology Clinic(Tokyo)
2019 | Year | 02 | Month | 15 | Day |
Unpublished
20
Completed
2019 | Year | 02 | Month | 08 | Day |
2019 | Year | 02 | Month | 08 | Day |
2019 | Year | 02 | Month | 17 | Day |
2019 | Year | 03 | Month | 17 | Day |
2019 | Year | 02 | Month | 15 | Day |
2019 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040881
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