Unique ID issued by UMIN | UMIN000040039 |
---|---|
Receipt number | R000045650 |
Scientific Title | Changes in gut microbiome and verification of effective dose by test food intake -Randomized double-blind parallel group comparison method- |
Date of disclosure of the study information | 2020/04/10 |
Last modified on | 2021/04/05 08:07:47 |
Changes in gut microbiome and verification of effective dose by test food intake
Changes in gut microbiome and verification of effective dose by test food intake
Changes in gut microbiome and verification of effective dose by test food intake
-Randomized double-blind parallel group comparison method-
Changes in gut microbiome and verification of effective dose by test food intake
-Randomized double-blind parallel group comparison method-
Japan |
Healthy adult male and female
Adult |
Others
NO
This study examines the effects of test food intake on the changes in gut microbiome
Efficacy
Composition ratio of gut microbiome
-Defecation status
-Gastrointestinal condition and appetite
-Mood status
-Skin condition and sleep quality
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
10
Prevention
Food |
Intake of the low dose of prebiotics material + polymer material dose1, once a day for 2 weeks
Intake of the low dose of prebiotics material + polymer material dose2, once a day for 2 weeks
Intake of the low dose of prebiotics material + polymer material dose3, once a day for 2 weeks
Intake of the low dose of prebiotics material + polymer material dose4, once a day for 2 weeks
Intake of the low dose of prebiotics material + polymer material dose5, once a day for 2 weeks
Intake of the high dose of prebiotics material + polymer material dose1, once a day for 2 weeks
Intake of the high dose of prebiotics material + polymer material dose2, once a day for 2 weeks
Intake of the high dose of prebiotics material + polymer material dose3, once a day for 2 weeks
Intake of the high dose of prebiotics material + polymer material dose4, once a day for 2 weeks
Intake of the high dose of prebiotics material + polymer material dose5, once a day for 2 weeks
20 | years-old | <= |
60 | years-old | > |
Male and Female
(1)Japanese healthy male and female aged 20-60 years whose defecation frequency is 3-5 times a week
(2)Subjects who have low-level Bifidobacterium at the point of screening
(3)Subjects who usually take three meals a day
(4)Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to consent, have well understood, volunteered to participate, and have signed the informed consent document
(1)Subjects who usually take intestinal drugs and laxatives
(2)Subjects who cannot stop the consumption of healthy foods which may have good effect on constipation during the test period
(3)Subjects who usually take healthy supplements
(4)Subjects who cannot stop the consumption of foods which are containing lactic acid bacteria, bifidobacteria, oligosaccharides, and natto bacteria (probiotics and prebiotics materials )
(5)Subjects who have gastrointestinal disorders or a surgical history and who usually take gastrointestinal drugs
(6)Subjects who have been diagnosed irritable bowel syndrome or inflammatory bowel disease
(7)Subjects who have liver disease, kidney disease and diabetes mellitus
(8)Subjects who have allergic to food
(9)Subjects who have pollinosis and take drugs which affects gut microbiome
(10)Subjects who are pregnant or breast-feeding, or planning to be pregnant during the test period
(11)Subjects who participate in other clinical trials (food, pharmaceuticals and cosmetics), who have participated in other tests within one month of obtaining consent, or who are willing to participate
(12)Subjects who are judged as unsuitable for the study by the investigators
100
1st name | Tomoyuki |
Middle name | |
Last name | Mine |
Ajinomoto Co., Inc.
Institute of Food Sciences and Technologies
2108681
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
044-223-4114
tomoyuki_mine@ajinomoto.com
1st name | Kentaro |
Middle name | |
Last name | Umeda |
Ajinomoto Co., Inc.
Institute of Food Sciences and Technologies
2108681
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
044-223-4114
kentaro_umeda@ajinomoto.com
KSO Corporation
Ajinomoto Co., Inc
Profit organization
KSO Corporation
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
医療法人財団健康睡眠会 日本橋循環器科クリニック
2020 | Year | 04 | Month | 10 | Day |
Unpublished
100
Completed
2020 | Year | 02 | Month | 19 | Day |
2020 | Year | 06 | Month | 25 | Day |
2020 | Year | 08 | Month | 15 | Day |
2021 | Year | 01 | Month | 31 | Day |
2020 | Year | 04 | Month | 03 | Day |
2021 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045650
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |