Unique ID issued by UMIN | UMIN000018958 |
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Receipt number | R000021933 |
Scientific Title | A randomized double-blind placebo-controlled trial for improving the intestinal environment in human |
Date of disclosure of the study information | 2015/09/09 |
Last modified on | 2017/01/30 18:42:23 |
A randomized double-blind placebo-controlled trial for improving the intestinal environment in human
A trial for improving the intestinal environment in human
A randomized double-blind placebo-controlled trial for improving the intestinal environment in human
A trial for improving the intestinal environment in human
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To investigate the effect of test foods on the intestinal environment in human
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Intestinal bacterial flora (T-RFLP)
1. Intestinal bacterial flora (real-time PCR)
2. T-regulatory cell (T-reg)
3. The Japanese Version of the Constipation Assessment Scale MT version (CAS-MT)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
3
Treatment
Food |
Period: 4 weeks
Test food: Baker's yeast extract (0.5 g)
Dose: three times a day (0.5 g for once)
Usage: ingestion of the test food along with the water or hot water after each meals
Period: 4 weeks
Test food: Baker's yeast extract {Baker's yeast extract (0.08 g)+ dextrin (0.42 g)}
Dose: three times a day (0.5 g for once)
Usage: ingestion of the test food along with the water or hot water after each meals
Period: 4 weeks
Test food: Placebo (dextrin; 0.5 g)
Dose: three times a day (0.5 g for once)
Usage: ingestion of the test food along with the water or hot water after each meals
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese healthy adults
2. The person who has a tendency for the loose stools
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, digestive disease (include colonic diverticulosis, ulcerative colitis, Diverticular Disease of the Colon) or other chronic diseases
3. Currently taking medicines, herbal medicines
4. Usually taking Food for Specified Health Uses (FOSHU), Functional Labeling System on health foods, yogurt or lactic acid bacteria beverage, which are related with intestinal regulation.
5. Allergic to medicines or foods related to the test food of this trial
6. Usually taking supplements or nutrient function foods in daily
7. Pregnant, lactating, or planning to get pregnant during the trial period
8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial
9. Judged unsuitable for participating in this trial by physician
24
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO, Inc.
Ministry of Agriculture, Forestry and Fisheries / The agriculture and forestry marine products industry, food industry technology study promotion project
Japanese Governmental office
Seishin-kai Medical Association Inc, Takara Medical Clinic.
ORIENTAL YEAST Co., Ltd.
NO
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
2015 | Year | 09 | Month | 09 | Day |
Unpublished
Completed
2015 | Year | 09 | Month | 07 | Day |
2015 | Year | 09 | Month | 10 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 09 | Month | 09 | Day |
2017 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021933
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