Unique ID issued by UMIN | UMIN000017271 |
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Receipt number | R000020043 |
Scientific Title | Double-Blind, Placebo-Controlled Study for Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC). |
Date of disclosure of the study information | 2015/04/24 |
Last modified on | 2015/04/28 09:55:56 |
Double-Blind, Placebo-Controlled Study for Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC).
Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC).
Double-Blind, Placebo-Controlled Study for Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC).
Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC).
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To evaluate and investigate whether supplementation with green onion extract (GON) alone or with concomitant use of AHCC daily for 4 weeks will be effective for immunopotentiative action.
Efficacy
Confirmatory
Pragmatic
Not applicable
Natural Killer cell activity, immune score (lymphocyte subset analysis by flow cytometry method)
Leukocyte counts, differential leukocyte count, serum MCP-1, IgG, IgM, salivary IgA, common cold questionnaire(CCQ), VAS (stress, fatigue, etc.), questionnaire about change in physical condition
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
5
Treatment
Food |
Daily intake of 4 capsules containing low-dose GON for 4 weeks.
Daily intake of 4 capsules containing high-dose GON for 4 weeks.
Daily intake of 4 capsules containing AHCC for 4 weeks.
Daily intake of 4 capsules containing GON and AHCC for 4 weeks.
Placebo: Daily intake of 4 capsules containing dextrin for 4 weeks.
30 | years-old | <= |
75 | years-old | > |
Male and Female
1. Japanese men and women age more than 30 less than 75
2. Subjects who have chronic fatigue or difficulty in recovery from fatigue.
3. Subjects who have weakened immune systems (who had relatively low in NK cells activity or immunity score from the results of a screening test)
4. Subjects who agree to participate in the current study and provide a written informed consent.
1. Subjects under medication for chronic diseases (especially related to cancer, hepatic, renal, cardiac, gastrointestinal or mental disorders, diabetes, dyslipidemia and/or hypertension
2. Subjects who have severe cerebral, vascular, cardiac, hepatic, renal and / or gastric disorders
3. Subjects who are suspectedly infected with an acute infection such as influenza, etc.
4. Subjects with ongoing treatment of autoimmune disorder, chronic inflammatory and / or allergic disease
5. Subjects who were vaccinated in the last 12 weeks or intend to be vaccinated during the trial period.
6. Subjects who have a history of gastrectomy, gastrorrhaphy, enterectomy and/ or other serious gastrointestinal surgeries.
7. Pre- or post-menopausal women having obvious changes in physical condition
8. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
9. Subjects who have a serious anemia.
10. Subjects who have a history of allergy or sensitivity to medicine and / or food (especially green onions, mushrooms, and gelatin).
11. Subjects who regularly take medicine (antibiotics, immunosuppressant, antirheumatic, anti-inflammatory, antihistamine, antiallergic, lactobacillus preparation), traditional Chinese medicine, health food, supplements (mushrooms, seaweed, nucleic acid, yeast and/or lactobacillus) which may affect immunity function.
12. Heavy smokers and alcohol addicts, or having irregular lifestyle.
13. Subjects who donated 400ml whole blood within the past 12 weeks or donated plasma or platelets within the last 4 weeks prior to supplementation.
14. Pregnant or lactating women, or women expect to be pregnant during the clinical trial
15. Subjects who participated in other clinical trials within the last one month prior to the clinical trial
16. Any other medical reasons judged by the responsible doctor
75
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Health Information Science Center
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
NOASTEC Foundation (Northern Advancement Center for Science and Technology)
Non profit foundation
Japan
Amino Up Chemical Co., Ltd.
NO
北海道情報大学 保健センター(北海道)
2015 | Year | 04 | Month | 24 | Day |
Partially published
Completed
2013 | Year | 10 | Month | 11 | Day |
2013 | Year | 11 | Month | 01 | Day |
2013 | Year | 12 | Month | 15 | Day |
2013 | Year | 12 | Month | 19 | Day |
2014 | Year | 01 | Month | 28 | Day |
2014 | Year | 03 | Month | 05 | Day |
2015 | Year | 04 | Month | 24 | Day |
2015 | Year | 04 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020043
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