UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy Test for Immune Function by Daily Ingestion of Test Food: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym	Efficacy Test for Immune Function by Daily Ingestion of Test Food
Scientific Title	Efficacy Test for Immune Function by Daily Ingestion of Test Food: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym	Efficacy Test for Immune Function by Daily Ingestion of Test Food
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	NK cell activity at 4, 8, and 12 weeks after beginning the intake of test food.
Key secondary outcomes	IFN-gamma, the Brief Job Stress Questionnaire (Section B).

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
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion of 4 capsules of test food for 12 weeks.
Interventions/Control_2	Daily ingestion of 4 capsules of dextrin for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	24

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

Public contact
Name of contact person	1st name Naoyuki Middle name Last name HONMA
Organization	Hokkaido Information University
Division name	Health Information Science Center
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, Japan
TEL	011-385-4430
Homepage URL
Email	hisc-acad.res@s.do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	LAB biotech Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics committee of Hokkaido Information University
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel	011-385-4411
Email	soumu@do-johodai.ac.jp

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	2021 Year 04 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2021 Year 03 Month 24 Day
Date of IRB	2021 Year 03 Month 24 Day
Anticipated trial start date	2021 Year 05 Month 14 Day
Last follow-up date	2021 Year 09 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 06 Day
Last modified on	2021 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050053