UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059638 |
|---|---|
| Receipt number | R000068211 |
| Scientific Title | Study to verify the effects on immune function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/11/04 20:14:20 |
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Basic information
Public title
Study to verify the effects on immune function in healthy Japanese
Acronym
Study to verify the effects on immune function in healthy Japanese
Scientific Title
Study to verify the effects on immune function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Study to verify the effects on immune function in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food consumption on immune function in healthy Japanese.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Measured value of the immunological vigor score at 8 weeks after intervention (8w)
Key secondary outcomes
1. Cumulative number of days with cold-like symptoms, maximum duration, and number of onset occurrences per participant during the study period
2. Number of participants exhibiting cold-like symptoms during the study period
3. Cumulative number of days, maximum duration, number of onset occurrences, and severity of general malaise, chills, feverishness, fatigue, sneezing, runny nose, nasal congestion, sore throat, cough, joint pain, muscle pain, and headache for each participant during the study period
4. Number of participants exhibiting general malaise, chills, feverishness, fatigue, sneezing, runny nose, nasal congestion, sore throat, cough, joint pain, muscle pain, and headache during the study period
5. Immunological vigor grade, T lymphocyte age (lower limit), T lymphocyte age (upper limit), CD3+ T cell percentage, CD3+ T cell count, CD3+ T cell count score, CD4+ T cell percentage, CD4+ T cell count, CD8+ T cell percentage, CD8+ T cell count, CD4+ T cell count/CD8+ T cell count ratio, CD4+ T cell count/CD8+ T cell count ratio score, naive T cell percentage, naive T cell count, naive T cell count score, memory T cell percentage, memory T cell count, naive T cell count/memory T cell count ratio, naive T cell count/memory T cell count ratio score, CD56+16- natural killer (NK) cell percentage, CD56+16+ NK cell percentage, NK cell count, NK cell count score, B cell percentage, B cell count, B cell count score, CD8+CD28+ T cell percentage, CD8+CD28+ T cell count, and CD8+CD28+ T cell count score at 8w
6. Relative abundance of fecal bacteria and alpha diversity index at 8w
7. Measured values of white blood cell count (WBC), white blood cell differential (neutrophil percentage, lymphocyte percentage, monocyte percentage, eosinophil percentage, and basophil percentage) at 8w
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 8 weeks
Test product: Gamma-oligosaccharide inclusion complex of Brazilian green propolis supercritical extract (low dose)
Administration: Consume four tablets daily with water after the first meal of the day.
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
Interventions/Control_2
Duration: 8 weeks
Test product: Gamma-oligosaccharide inclusion complex of Brazilian green propolis supercritical extract (high dose)
Administration: Consume four tablets daily with water after the first meal of the day.
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
Interventions/Control_3
Duration: 8 weeks
Test product: Placebo
Administration: Consume four tablets daily with water after the first meal of the day.
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medications (including herbal medicines) or supplements
6. Individuals who are allergic to medicines or foods related to the test product
7. Individuals with suspected asthma
8. Individuals who are pregnant, lactating, or planning to become pregnant during this study
9. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
10. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Fujimi Beehouse Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fujimi Beehouse 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 04 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068211
