Unique ID issued by UMIN | UMIN000053194 |
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Receipt number | R000060705 |
Scientific Title | Effects of consumption of the test food on immune function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/12/22 |
Last modified on | 2024/03/15 10:11:06 |
Effects of consumption of the test food on immune function in healthy Japanese
Effects of consumption of the test food on immune function in healthy Japanese
Effects of consumption of the test food on immune function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on immune function in healthy Japanese
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the food on immune function in healthy Japanese.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured values of median fluorescence intensity (MFI) for CD40, CD80, CD86, and human leukocyte antigen-DR (HLA-DR) in plasmacytoid dendritic cells (pDC) at 12 weeks after consumption (12w)
1. The measured values of positive cell percentages for CD40, CD80, CD86, and HLA-DR in pDC at 12w
2. The measured values of interferon-alpha 2a (IFN-alpha 2a), natural killer (NK) cell activity, salivary secretory immunoglobulin A (sIgA) at 12w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
YES
2
Prevention
Food |
Duration: 12 weeks
Test food: Tablet containing Tetragenococcus halophilus No.1
Administration: Take one tablet with water at the breakfast once a day
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks
Test food: Tablet not containing Tetragenococcus halophilus No.1
Administration: Take one tablet with water at the breakfast once a day
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who are aware that they get sick easily or catch a cold easily
6. Individuals whose MFI of pDC is relatively low at screening (before consumption) among those who meet inclusion criteria No. 1~5 without meeting any of exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who have autoimmune disease
5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
6. Individuals who are taking medications (including herbal medicines) and supplements
7. Individuals who use immunosuppressants such as steroid
8. Individuals who are allergic to medicines and/or the test food related products
9. Individuals who have pollen allergies
10. Individuals who are pregnant, lactating, or planning to become pregnant during this study
11. Individuals who suffer from COVID-19
12. Individuals whose working hours are irregular
13. Individuals who have irregular lifestyles (such as diet, exercise, and sleep)
14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
15. Individuals who are judged as ineligible to participate in this study by the physician
16. Individuals who have received vaccination for influenza virus within the last three months before the agreement to participate in this study
34
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.
Ichibiki 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 Bldg., 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)
2023 | Year | 12 | Month | 22 | Day |
Unpublished
40
No longer recruiting
2023 | Year | 12 | Month | 13 | Day |
2023 | Year | 12 | Month | 13 | Day |
2023 | Year | 12 | Month | 22 | Day |
2024 | Year | 06 | Month | 28 | Day |
2023 | Year | 12 | Month | 22 | Day |
2024 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060705
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