UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Plant-Derived Products on Mucosal Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Study on the Effect of Plant-Derived Products on Mucosal Immune Function
Scientific Title	A Study on the Effect of Plant-Derived Products on Mucosal Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Study on the Effect of Plant-Derived Products on Mucosal Immune Function
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of plant-derived products on mucosal immune function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	salivary sIgA
Key secondary outcomes	Incidence of symptoms of the common cold

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Plant-Derived Products, 8 weeks consumption
Interventions/Control_2	Placebo Products, 8 weeks consumption
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Healthy males and females aged 20 to 64 years-old. (2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	Subjects (who) (1)have never had an upper respiratory tract infection or viral gastroenteritis in the last two winters. (2)have a faster salivary sIgA secretion rate. (3)contract diseases (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease). (4)have a chronic disease and regularly use medications. (5)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions. (6)can't stop taking foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, and/or live bacteria during test periods. (7)regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides. (8)get intense exercises (e.g., muscle training in the gym) more than 3 times a week. (9)are under treatment for periodontal disease. (10)used antibiotics within the last two weeks prior to the screening. (11)can't stop drinking from 2 days before each measurement. (12)have declared allergic reaction to ingredients of test foods. (13)have a history of and/or contract pollinosis and/or allergic rhinitis. (14)have a history and/or a surgical history of digestive disease affecting digestion and absorption. (15)plan to become pregnant after informed consent, pregnant or lactating. (16)are judged unsuitable for the study by the screening. (17)have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last 3 months prior to the study. (18)are under treatment for or have a history of drug addiction and/or alcoholism. (19)are shiftworker, midnight-shift worker and/or teleworker. (20)are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the study. (21)are judged unsuitable for the study by the investigator for other reasons.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Tokushima
Organization	Maebashi North Hospital
Division name	Director
Zip code	371-0054
Address	692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL	027-235-3333
Email	sagawa@mc-connect.co.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel	027-212-5608
Email	sagawa@mc-connect.co.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

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 04 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	2020 Year 11 Month 20 Day
Date of IRB	2020 Year 12 Month 03 Day
Anticipated trial start date	2020 Year 12 Month 07 Day
Last follow-up date	2021 Year 04 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 04 Day
Last modified on	2021 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048667