Unique ID issued by UMIN | UMIN000027836 |
---|---|
Receipt number | R000031887 |
Scientific Title | The verification study for improving the intestinal environment: A randomized double-blind placebo-controlled trial |
Date of disclosure of the study information | 2017/06/20 |
Last modified on | 2021/05/28 13:25:16 |
The verification study for improving the intestinal environment: A randomized double-blind placebo-controlled trial
The verification study for improving the intestinal environment
The verification study for improving the intestinal environment: A randomized double-blind placebo-controlled trial
The verification study for improving the intestinal environment
Japan |
Healthy Japanese adults
Not applicable | Adult |
Others
NO
To verify the effects of the test food on defecation
Safety,Efficacy
Confirmatory
Pragmatic
1. Bowel movement diary
2. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*1 Keep it from a week before screening test and a week before consuming to 4 weeks after consuming
*2 Assess at 0 and 4 weeks after consuming
1. Bacterial flora analysis (T-RFLP)
2. Bristol scale
*1,2 Assess at 0 and 4 weeks after consuming
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 |
Duration: 4 weeks
Test materials: Konjac processed food
Dose: 1 pack a day
Administration: Take 1 pack in the morning. If you take breakfast, take the test food 15 minutes before breakfast.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.
Duration: 4 weeks
Test materials: Konjac processed food
Dose: 2 packs a day (1 pack for once)
Administration: Take 1 pack in the morning and evening. If you take either breakfast or dinner, take the test food 15 minutes before the meal.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.
Duration: 4 weeks
Test materials: Placebo
Dose: 1 pack a day
Administration: Take 1 pack in the morning. If you take breakfast, take the test food 15 minutes before breakfast.
*If you forget ingestion of the test food, take it as soon as you remember within the day. When it is before the meal, you take the test food 15 minutes before the meal.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults
2. Those who defecate three to five times per week
3. Those who are considered as appropriate for the study by the physician
4. Among the people who passed 3., 3 or more male and 3 or more female are selected from each generation (20s, 30s, 40s, 50s, and 60s). (e.g., 6 or more people are selected from each generation.)
5. Among the people who passed 4., those who have relatively few defecation frequency during a week before screening and advance examination
6. Among the people who passed 5., those who have relatively high score in the Japanese version of Constipation Assessment Scale MT version (CAS-MT)
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
4. Currently taking medicines and/or herbal medicines
5. Those who are allergic to medicines, milk, beans, orange, and/or other food products
6. Those who are pregnant, breast-feeding, and plan to become a pregnant
7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial
8. Others considered as inappropriate for the study by the physician
30
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
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.
ORIHIRO Plantdew Co.,Ltd.
Profit organization
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)
2017 | Year | 06 | Month | 20 | Day |
Unpublished
Published
http://www.pieronline.jp/content/article/0386-3603/47090/1445
33
Gokan N, Hoshino T, Takara T. Improvement of the Intestinal Environment by Konjac Processed Food-A Randomized, Double-blind, Placebo-controlled, Parallel-group Comparison Trial-. Jpn Pharmacol Ther. 2019; 47(9): 1445-1454
2021 | Year | 05 | Month | 28 | Day |
2019 | Year | 10 | Month | 02 | Day |
Refer to the paper
Refer to the paper
Refer to the paper
Refer to the paper
Undecided
To require consultation among related companies
Completed
2017 | Year | 06 | Month | 19 | Day |
2017 | Year | 06 | Month | 21 | Day |
2017 | Year | 06 | Month | 20 | Day |
2021 | Year | 05 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031887
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