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
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
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
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
