UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017271
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

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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 or person

Institute

Hokkaido Information University

Institute

Department

Personal name



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

Value
https://center6.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