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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043856
Receipt No. 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 2021/04/06

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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 Jun
Middle name
Last name NISHIHIRA
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 nishihira@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 Preinitiation
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 04 Month 06 Day


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

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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