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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043386
Receipt No. R000049527
Scientific Title A Study on the Effect of Plant-Derived Product on Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2021/02/20
Last modified on 2021/02/19

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Basic information
Public title A Study on the Effect of Plant-Derived Product on Immune Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym A Study on the Effect of Plant-Derived Product on Immune Function
Scientific Title A Study on the Effect of Plant-Derived Product on Immune Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym A Study on the Effect of Plant-Derived Product on 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 immune function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Salivary sIgA
Key secondary outcomes Skin moisture content
Physical condition questionnaire

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, 4 weeks consumption
Interventions/Control_2 Placebo Products, 4 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 a faster salivary sIgA secretion rate.
(2)have a constipation tendency.
(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)get intense exercises (e.g., muscle training in the gym) more than 3 times a week.
(8)are under treatment for periodontal disease.
(9)used antibiotics within the last two weeks prior to the screening.
(10)can't stop drinking from a day before each measurement.
(11)have declared an allergic reaction to test foods.
(12)have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(13)plan to become pregnant after informed consent, pregnant or lactating.
(14)are under treatment for or have a history of drug addiction and/or alcoholism.
(15)are shiftworker and/or midnight-shift worker.
(16)are participating and/or had participated and/or are planning to participate in other clinical studies that affect this study.
(17)with skin disease, such as atopic dermatitis.
(18)with strange skin conditions at measurement points.
(19)neglect skin care.
(20)can't avoid direct sunlight exposure, such as sunburn, during test periods.
(21)had been conducted an operation or beauty treatment on the test spot in the past 6 months.
(22)are judged unsuitable for the study by the investigator for other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Kado
Organization TOYO SHINYAKU Co., Ltd.
Division name Clinical and analytical research center
Zip code 841-0005
Address 7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL 0942-81-3555
Email kadot@toyoshinyaku.co.jp

Public contact
Name of contact person
1st name Nobutaka
Middle name
Last name Kusaba
Organization TOYO SHINYAKU Co., Ltd.
Division name Clinical and analytical research center
Zip code 841-0005
Address 7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL 0942-81-3555
Homepage URL
Email gakujutsu@toyoshinyaku.co.jp

Sponsor
Institute TOYO SHINYAKU Co., Ltd.
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 Miura Clinic, Medical Corporation Kanonkai IRB
Address 9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
Tel 06-6135-5200
Email mterashima@miura-cl.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
2021 Year 02 Month 20 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 02 Month 01 Day
Date of IRB
2021 Year 02 Month 18 Day
Anticipated trial start date
2021 Year 03 Month 01 Day
Last follow-up date
2021 Year 04 Month 30 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 02 Month 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049527

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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