UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042653
Receipt number R000048667
Scientific Title A Study on the Effect of Plant-Derived Products on Mucosal Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2020/12/04
Last modified on 2021/07/19 16:36:50

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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 or person

Institute

KSO Corporation

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048667


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name