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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017271
Receipt No. 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

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Basic information
Public title Double-Blind, Placebo-Controlled Study for Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC).
Acronym Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC).
Scientific Title Double-Blind, Placebo-Controlled Study for Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC).
Scientific Title:Acronym Immunopotentiative Effects of Green Onion Extract (GON) and Active Hexose Correlated Compound (AHCC).
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Natural Killer cell activity, immune score (lymphocyte subset analysis by flow cytometry method)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily intake of 4 capsules containing low-dose GON for 4 weeks.
Interventions/Control_2 Daily intake of 4 capsules containing high-dose GON for 4 weeks.
Interventions/Control_3 Daily intake of 4 capsules containing AHCC for 4 weeks.
Interventions/Control_4 Daily intake of 4 capsules containing GON and AHCC for 4 weeks.
Interventions/Control_5 Placebo: Daily intake of 4 capsules containing dextrin for 4 weeks.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization NOASTEC Foundation (Northern Advancement Center for Science and Technology)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Amino Up Chemical Co., Ltd.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2013 Year 12 Month 15 Day
Date of closure to data entry
2013 Year 12 Month 19 Day
Date trial data considered complete
2014 Year 01 Month 28 Day
Date analysis concluded
2014 Year 03 Month 05 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 24 Day
Last modified on
2015 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020043

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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