Unique ID issued by UMIN | UMIN000043856 |
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Receipt number | R000050053 |
Scientific Title | Efficacy Test for Immune Function by Daily Ingestion of Test Food: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study |
Date of disclosure of the study information | 2021/04/07 |
Last modified on | 2021/12/16 16:10:38 |
Efficacy Test for Immune Function by Daily Ingestion of Test Food: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Efficacy Test for Immune Function by Daily Ingestion of Test Food
Efficacy Test for Immune Function by Daily Ingestion of Test Food: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Efficacy Test for Immune Function by Daily Ingestion of Test Food
Japan |
Healthy adults
Adult |
Others
NO
To investigate the efficacy associated with immune function on 12 weeks daily ingestion of test food in a randomized, double-blind, placebo-controlled, parallel group study.
Safety,Efficacy
Exploratory
Pragmatic
NK cell activity at 4, 8, and 12 weeks after beginning the intake of test food.
IFN-gamma, the Brief Job Stress Questionnaire (Section B).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
YES
No need to know
2
Prevention
Food |
Daily ingestion of 4 capsules of test food for 12 weeks.
Daily ingestion of 4 capsules of dextrin for 12 weeks.
50 | years-old | <= |
70 | years-old | > |
Male and Female
1.Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2.Subjects with relatively low NK cell activity.
1.Subjects who are under treatment or medication for autoimmune diseases, chronic inflammatory diseases, allergies, thrombocytopenia, and hypertension.
2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
3.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4.Subjects with unusually high and/or low blood pressure and/or abnormal physical data and hematological data.
5.Subjects with severe anemia.
6.Pre- or post-menopausal women complaining of obvious physical changes.
7.Subjects who are at risk of having allergic reactions to drugs or foods (especially mushrooms).
8.Subjects who regularly take medicines, functional foods, and/or supplements which would affect the immune function.
9.Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
10.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
11.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
12.Subjects determined to be ineligible by the principal investigator.
24
1st name | Jun |
Middle name | |
Last name | NISHIHIRA |
Hokkaido Information University
Department of Medical Management and Informatics
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | Naoyuki |
Middle name | |
Last name | HONMA |
Hokkaido Information University
Health Information Science Center
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Hokkaido Information University
LAB biotech Ltd.
Profit organization
Japan
The ethics committee of Hokkaido Information University
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
soumu@do-johodai.ac.jp
NO
北海道情報大学保健センター(北海道)
2021 | Year | 04 | Month | 07 | Day |
Unpublished
Completed
2021 | Year | 03 | Month | 24 | Day |
2021 | Year | 03 | Month | 24 | Day |
2021 | Year | 05 | Month | 14 | Day |
2021 | Year | 09 | Month | 08 | Day |
2021 | Year | 04 | Month | 06 | Day |
2021 | Year | 12 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050053
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