Unique ID issued by UMIN | UMIN000020165 |
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Receipt number | R000023298 |
Scientific Title | Validation study for intentional flora effects with "health beverage" in healthy Japanese adults: a double-blind randomized controlled trial |
Date of disclosure of the study information | 2015/12/11 |
Last modified on | 2017/01/30 18:45:40 |
Validation study for intentional flora effects with "health beverage" in healthy Japanese adults: a double-blind randomized controlled trial
Validation study for intentional flora effects with "health beverage" in healthy Japanese adults
Validation study for intentional flora effects with "health beverage" in healthy Japanese adults: a double-blind randomized controlled trial
Validation study for intentional flora effects with "health beverage" in healthy Japanese adults
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
We investigate the effect of "health beverage" to intentional flora in healthy Japanese adults.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Intestinal bacterial flora (0 weeks & 12 weeks)
Measure pH of stool (0 weeks & 12 weeks)
High sensitivity CRP (0 weeks & 12 weeks)
The Japanese Version of the Constipation Assessment Scale MT version (0 weeks & 12 weeks)
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
2
Treatment
Food |
Period: 12 weeks
Test food: "health beverage"
Dose: Drink 1 bottle of "health beverage", three times a day
Usage: Drink 1 bottle of "health beverage" with the meal (morning, lunch, and dinner)
Period: 12 weeks
Test food: water (placebo)
Dose: Drink 1 bottle of water, once a day
Usage: intake at optional timing
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults
2. The person who defecate three to five times per week
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 or other chronic diseases
3. Currently taking medicines (including Chinese medicines), herbal medicines
4. Usually taking Food for Specified Health Uses (FOSHU), Functional display food, 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
20
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.
Atom Japan, INC.
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
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 | 12 | Month | 11 | Day |
Unpublished
Completed
2015 | Year | 12 | Month | 07 | Day |
2015 | Year | 12 | Month | 14 | Day |
2016 | Year | 07 | Month | 20 | Day |
2016 | Year | 07 | Month | 20 | Day |
2016 | Year | 07 | Month | 20 | Day |
2016 | Year | 07 | Month | 20 | Day |
2015 | Year | 12 | Month | 11 | Day |
2017 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023298
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