Unique ID issued by UMIN | UMIN000042195 |
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Receipt number | R000048166 |
Scientific Title | Effects of consumption of the test food on the immune function: A randomized, double-blind, placebo-controlled, parallel-group comparison trial |
Date of disclosure of the study information | 2020/10/21 |
Last modified on | 2022/10/28 14:17:51 |
Effects of consumption of the test food on the immune function
Effects of consumption of the test food on the immune function
Effects of consumption of the test food on the immune function: A randomized, double-blind, placebo-controlled, parallel-group comparison trial
Effects of consumption of the test food on the immune function
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of 8-week consumption of the test food on the immune function
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
The cumulative number of days with common cold symptoms during the intervention period per subject
1. The maximum duration of the days with common cold symptoms during the intervention period per subject
2. The cumulative number of days with common cold symptoms during the intervention period per group
3. The percentage of subjects who have infected with the influenza virus during the intervention period
4. The measured values and changes from screening and advance examination of the following items at four and eight weeks after consumption:
physical component summary (PCS), mental component summary (MCS), physical functioning, role physical, bodily pain, general health, social functioning, role emotional, mental health, scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit), the score of T cells, the score of CD8+CD28+T cells, the score of ratio of CD4+T cells to CD8+T cells, the score of naive T cells, the score of ratio of naive T cells to memory T cells, the score of B cells, the score of NK cells, the number of T cells, the ratio of CD4+T cells to CD8+T cells, the number of naive T cells, the ratio of naive T cells to memory T cells, the number of B cells, the number of NK cells, the number of CD8+CD28+T cells, and salivary IgA
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
2
Prevention
Food |
Duration: Eight weeks
Test food: Sulforaphane glucosinolate powder
Administration: Take one pack per day at any time during the day
* Daily dose should be taken within the day.
Duration: Eight weeks
Test food: Placebo powder
Administration: Take one pack per day at any time during the day
* Daily dose should be taken within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who catch colds easily
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects who have relatively low scoring of general health in SF-8 (SF8 Health Survey) at screening (before consumption)
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. 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 are pollen allergy
5. Subjects who have a past or current medical history of respiratory disease
6. Subjects who have an autoimmune disease
7. Subjects who are taking immunosuppressants such as steroids
8. Subjects who have received vaccination for infectious diseases such as influenza
9. Subjects who have a vigorous exercise habit
10. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
11. Subjects who take broccoli sprouts in daily
12. Subjects who are currently taking medications (including herbal medicines) and supplements
13. Subjects who are allergic to medicines and/or the test food related products
14. Subjects who are pregnant, breast-feeding, and planning to become pregnant
15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
16. Subjects who are judged as ineligible to participate in the study by the physician
60
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.
MURAKAMI FARM 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 | 10 | Month | 21 | Day |
Unpublished
66
Completed
2020 | Year | 10 | Month | 16 | Day |
2020 | Year | 10 | Month | 16 | Day |
2020 | Year | 10 | Month | 22 | Day |
2021 | Year | 04 | Month | 02 | Day |
2020 | Year | 10 | Month | 21 | Day |
2022 | Year | 10 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048166
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