Unique ID issued by UMIN | UMIN000041340 |
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Receipt number | R000047170 |
Scientific Title | Evaluation of immunostimulatory effects of test food intake |
Date of disclosure of the study information | 2020/08/17 |
Last modified on | 2021/02/04 17:00:30 |
Evaluation of immunostimulatory effects of test food intake
Evaluation of immunostimulatory effects of test food intake
Evaluation of immunostimulatory effects of test food intake
Evaluation of immunostimulatory effects of test food intake
Japan |
Not applicable
Not applicable |
Others
NO
Evaluate the immunostimulatory effect of foods using blood IgA, IgG and NK cell activity as an indicator.
Safety,Efficacy
blood IgA
blood IgG
NK cell activity
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Intake 5 capsules those contain test food three times a day (after each meal), for 8 weeks.
Intake 5 capsules those contain no test food three times a day (after each meal), for 8 weeks.
30 | years-old | <= |
50 | years-old | > |
Male
1)Males and females aged 30 to 49 at resistration.
2)Subjects giving written informed consent.
1) Subjects who constantly use medicines, supplements having a possibility of affecting test results.
2) Subjects who have previous and/or current medical history of serious disease such a the heart, liver, kidneys, gastrointestinal tract, etc.
3) Subjects who excessive alcohol intake.
4) Subjects who excess smoker.
5) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
6) Subjects who have previous medical history of drug and/or food (especially gelatin) allergy.
7) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
8) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
9) Males who donated over 400mL blood and/or blood components within the last three month to the current study.
10)Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
11) Subjects who are positive for infectious.
12) Others who have been determined ineligible by principal investigator or sub-investigator.
20
1st name | Seiji |
Middle name | |
Last name | Shioda |
SHIODA Life Science Inc.
President
106-0031
Sunrise Roppongi Bildg. 3B, 3-2-9 NIshiazabu, Minato-ku, Tokyo, Japan
03-6804-5371
shioda@hoshi.ac.jp
1st name | Makoto |
Middle name | |
Last name | Ichinohe |
CPCC Company Limited
Sales & Planning Department
101-0047
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5927-3112
cpcc-contact@cpcc.co.jp
CPCC Company Limited
SHIODA Life Science Inc.
Profit organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
03-5297-5548
IRB@cpcc.co.jp
NO
2020 | Year | 08 | Month | 17 | Day |
Unpublished
Completed
2020 | Year | 06 | Month | 22 | Day |
2020 | Year | 06 | Month | 19 | Day |
2020 | Year | 08 | Month | 18 | Day |
2021 | Year | 11 | Month | 10 | Day |
2020 | Year | 08 | Month | 06 | Day |
2021 | Year | 02 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047170
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