UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056236 |
|---|---|
| Receipt number | R000064238 |
| Scientific Title | A Study for Evaluating the Effect of Plant-Derived Products on Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2024/11/22 |
| Last modified on | 2024/11/21 14:40:10 |
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Basic information
Public title
A Study for Evaluating the Effect of Plant-Derived Products on Immune Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A Study for Evaluating the Effect of Plant-Derived Products on Immune Function
Scientific Title
A Study for Evaluating the Effect of Plant-Derived Products on Immune Function
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A Study for Evaluating the Effect of Plant-Derived Products 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
cDC activity after 8 weeks consumption
Physical condition questionnaire up to 8 weeks consumption
Key secondary outcomes
cDC-related immune marker after 8 weeks consumption
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 are aware of tendency to upper respiratory infections.
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects(who)
1) contract, are under treatment for or have a history of serious diseases (e.g., diabetes, kidney/liver disease, heart disease, thyroid disease, adrenal disease and/or metabolic disease).
2) have a chronic disease and regularly use medications.
3) contract pollinosis, allergic rhinitis, atopic dermatitis, bronchial asthma, or chronic bronchitis.
4) have a history and/or a surgical history of digestive disease affecting digestion and absorption.
5) can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber during this study.
6) can't stop using supplements and/or functional foods (including Foods with Function Claims) affecting immune functions.
7) are smokers.
8) have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent.
9) have declared allergic reaction to ingredients of test foods.
10) can't stop drinking from 2 days before each measurement.
11) are under treatment for or have a history of drug addiction and/or alcoholism.
12) are shiftworker, midnight worker and/or physical labor.
13) are judged as unsuitable for the study by blood tests in screening test.
14) plan to become pregnant after informed consent, pregnant or lactating.
15) have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the screening test.
16) have a habit of strenuous exercise such as running or soccer.
17) are planning to go abroad, such as on an overseas trip.
18) have used drugs (including antiallergic drugs and antibiotics) that are thought to affect immune function within 2 weeks prior to the screening test.
19) are planning to participate and/or had participated in other clinical studies within the last 1 month prior to the current study.
20) are judged unsuitable for the study by the investigator for other reasons.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@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, Gunma
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
| 2024 | Year | 11 | Month | 22 | 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
| 2024 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064238
