Unique ID issued by UMIN | UMIN000047850 |
---|---|
Receipt number | R000054547 |
Scientific Title | A verification study of the improving effect of bowel movement by the test food consumption in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/05/25 |
Last modified on | 2024/04/10 09:29:41 |
A verification study of the improving effect of bowel movement by the test food consumption
A verification study of the improving effect of bowel movement by the test food consumption
A verification study of the improving effect of bowel movement by the test food consumption in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A verification study of the improving effect of bowel movement by the test food consumption in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the improving effect of bowel movement by the test food consumption in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
1. Defecation frequency at the 2nd week after consumption of the test food
1. Defecation frequency at the 1st week after consumption of the test food
2. Numbers of defecation days and amount of defecation at the 1st and 2nd week after consumption of the test food
3. Stool shape, stool smell, and exhilarating feeling of defecation at the 1st and 2nd week after consumption of the test food
4. The score of The Japanese Version of the Constipation Assessment Scale (CAS)
5. Each item of CAS
6. Bifidobacterium, Lactobacillales order, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium subcluster XIVa, Clostridium cluster XVIII
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
2
Treatment
Food |
Duration: Two weeks
Test food: Active food
Duration: Two weeks
Test food: Placebo food
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects whose defecation frequency is three to five times per week
6. Subjects who always have carbohydrates (such as rice, bread, and noodles) in every meal
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, lactation, or planning to become pregnant
8. Subjects who suffer from COVID-19
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
56
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
EGAO CO.,LTD.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2022 | Year | 05 | Month | 25 | Day |
Unpublished
Completed
2022 | Year | 05 | Month | 18 | Day |
2022 | Year | 05 | Month | 18 | Day |
2022 | Year | 05 | Month | 26 | Day |
2022 | Year | 09 | Month | 24 | Day |
2022 | Year | 05 | Month | 25 | Day |
2024 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054547