Unique ID issued by UMIN | UMIN000042783 |
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Receipt number | R000048835 |
Scientific Title | Effects of consumption of the test food on bowel movement: A randomized double-blind placebo-controlled, parallel-group trial |
Date of disclosure of the study information | 2020/12/18 |
Last modified on | 2021/07/28 11:19:48 |
Effects of consumption of the test food on bowel movement
Effects of consumption of the test food on bowel movement
Effects of consumption of the test food on bowel movement: A randomized double-blind placebo-controlled, parallel-group trial
Effects of consumption of the test food on bowel movement
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on bowel movement in healthy Japanese subjects.
Efficacy
Confirmatory
Pragmatic
Not applicable
The measured value of defecation frequency at period VI
1. The amounts of changes from periods I or II of defecation frequency in period VI
2. The measured values and amounts of changes from periods I or II of defecation frequency in periods III to V
3. The measured values and amounts of changes from periods I or II of defecation days and amount of defecation in periods III to V
4. The measured values of shape and smell of stool and exhilarating feeling in periods III to VI
5. The measured values and amounts of changes from screening (before consumption; Scr) of CAS score of CAS-MT at two and four weeks after consumption (2w, 4w)
6. The measured values of scores for each item of CAS-MT at 2w and 4w
7. The measured values and amounts of changes from Scr of the following items at 4w: total number of bacteria, numbers of lactic acid bacteria, Bifidobacterium, and Clostridium perfringens, salivary immunoglobulin A (s-IgA), scoring of immunological vigor, T lymphocyte age (upper limit), the numbers of T cells, naive T cells, B cells, NK cells, and CD8+CD28+T cells and the ratios of CD4+T cells to CD8+T cells and naive T cells to memory T cells
8. The measured values of the following items at 4w: immunological grade, the scores of T cells, CD8+CD28+T cell ratios, ratio of CD4+T cells to CD8+T cells, naive T cells, ratio of naive T cells to memory T cells, B cells, and NK cells
9. The cumulative number of days with each symptom listed on the diary report (#) and the common cold symptoms (*) during the intervention period per group
10. The cumulative number of days with each symptom listed on the diary report (#) and the common cold symptoms (*), and the maximum duration of the days with common cold symptoms (*) during the intervention period per subject
#: Feverishness, nasal discharge, blocked nose, throat pain, cough, sneezing, whole body malaise, muscle pain, joint pain, chilliness, fatigue, physical condition, and headache
*: The common cold symptom is defined as the onset of any one of #.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
4
Treatment
Food |
Duration: Four weeks
Test food: Tablets containing high levels of lactic acid bacteria
Administration: Take one tablet per day with water after dinner within 30 minutes
* Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.
Duration: Four weeks
Test food: Tablets containing moderate levels of lactic acid bacteria
Administration: Take one tablet per day with water after dinner within 30 minutes
* Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.
Duration: Four weeks
Test food: Tablets containing low levels of lactic acid bacteria
Administration: Take one tablet per day with water after dinner within 30 minutes
* Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.
Duration: Four weeks
Test food: Tablets without lactic acid bacteria
Administration: Take one tablet per day with water after dinner within 30 minutes
* Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Male or female
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects who defecate three to five times per week
6. Subjects who are aware that they easily feel fatigue and get sick.
7. Subjects who are judged as eligible to participate in the study by the physician
8. Subjects who have relatively few defecation frequency during a week before Scr
Subjects (who)
1.undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator
3.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.take "Foods for Specified Health Uses", "Foods with Functional Claims", foods containing viable fungi such as natto, yogurt, and fermented foods, foods fortified with oligosaccharides and dietary fiber, foods containing high amounts of sugar alcohol, food/beverage containing lactic acid bacteria, or other functional food/beverage in daily use and unable to quit the intake during the test period
5.regularly use medicines related to bowel movement, such as intestinal regulator and laxatives
6.currently taking medicines (include herbal medicines) and supplements
7.affected from pollen allergy
8.have received vaccination for infectious diseases such as influenza within a year
9.are smokers, or started smoking cessation within a year
10.drink an excess of alcohol
*weekly average of alcohol intake is more than 60 g/day [Reference materials for the promotion of Health Japan 21 (the second term)]
11.are planning to go abroad or have a job transfer during this trial
12.are allergic to medicines and/or the test food related products. Particularly, lactic acid bacteria, vitamin D, starch, sucrose fatty acid ester, or hydroxypropylmethylcellulose capsule
13.are lactating, pregnant, or intending to become pregnant
14.have been enrolled in other clinical trials within the last 3 months before the invitation to participate in this trial, or plan to participate in another trial during this trial
15.are judged by the principal investigator as ineligible to participate in the trial
80
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Building, 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.
Fujicco 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)
2020 | Year | 12 | Month | 18 | Day |
Unpublished
88
Completed
2020 | Year | 12 | Month | 11 | Day |
2020 | Year | 12 | Month | 11 | Day |
2020 | Year | 12 | Month | 18 | Day |
2021 | Year | 04 | Month | 10 | Day |
2020 | Year | 12 | Month | 18 | Day |
2021 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048835
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