Unique ID issued by UMIN | UMIN000043100 |
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Receipt number | R000049202 |
Scientific Title | Examination of the immunostimulatory effects of research food intake |
Date of disclosure of the study information | 2022/04/12 |
Last modified on | 2021/06/14 20:07:43 |
Examination of the immunostimulatory effects of research food intake
Examination of the immunostimulatory effects of research food intake
Examination of the immunostimulatory effects of research food intake
Examination of the immunostimulatory effects of research food intake
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the immunostimulatory effect of research food intake for 8 consecutive weeks
Efficacy
secretory IgA concentration in saliva, secretory IgA flow rate in saliva
QOL questionnaire, fatigue questionnaire
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Intake research food for 8 consecutive weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
Healthy males and females from 20 to 64 years of age with lower secretory IgA in saliva.
(1) Subjects who routinely use health food containing specific ingredients (ex. Resistant dextrin, Polydextrose, Resistant glucan etc. ).
(2) Subjects who constantly use medications affecting the immune system.
(3) Subjects who constantly use supplements and/or functional foods affecting the immune system.
(4) Subjects who intend to get vaccinated within 4 weeks or done.
(5) Subjects who have symptoms that affect the performance of the test.
(6) Subjects who get treatment affecting the test results.
(7) Night and day shift worker or manual laborer
(8) Subjects who habitually do intense exercise such as marathon.
(9) Subjects who cannot carry out inspection procedure as prescribed
(10) Subjects who are judged as having serious diseases
(11) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion
(12) Subjects having possibilities for emerging allergy related to the study
(13) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(14) Subjects who intend to become pregnant or lactating
(15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(17) Subjects judged as unsuitable for the study by the investigator for other reasons
10
1st name | Hiroki |
Middle name | |
Last name | Takagi |
NIHON SHOKUHIN KAKO CO., LTD.
RESEARCH INSTITUTE
417-8530
30 TAJIMA FUJI, SHIZUOKA
0545-53-5995
hiroki.takagi@nisshoku.co.jp
1st name | Kei |
Middle name | |
Last name | Yasui |
EP Mediate Co., Ltd.
Clinical Research Planning Department
162-0822
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
03-5657-4983
yasui475@eps.co.jp
EP Mediate Co., Ltd.
NIHON SHOKUHIN KAKO CO., LTD.
Profit organization
Medical Station Clinic Research Ethics Committee
3-12-8, Takaban, Meguroku, Tokyo
03-6452-2712
saito876@eps.co.jp
NO
2022 | Year | 04 | Month | 12 | Day |
Unpublished
10
Completed
2020 | Year | 12 | Month | 25 | Day |
2020 | Year | 12 | Month | 25 | Day |
2021 | Year | 01 | Month | 25 | Day |
2021 | Year | 04 | Month | 12 | Day |
2021 | Year | 01 | Month | 22 | Day |
2021 | Year | 06 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049202
Research Plan | |
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Research case data specifications | |
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Registered date | File name |
Research case data | |
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