UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058145 |
|---|---|
| Receipt number | R000066441 |
| Scientific Title | Investigation of the Immunomodulatory Effects of Continuous Consumption of the Test Supplement - A Randomized, Double-Blind, Parallel-Group Comparative Trial |
| Date of disclosure of the study information | 2026/10/12 |
| Last modified on | 2026/02/02 14:29:17 |
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Basic information
Public title
Investigation of the Immunomodulatory Effects of Continuous Consumption of the Test Supplement - A Randomized, Double-Blind, Parallel-Group Comparative Trial
Acronym
Investigation of the Immunomodulatory Effects of Continuous Consumption of the Test Supplement
Scientific Title
Investigation of the Immunomodulatory Effects of Continuous Consumption of the Test Supplement - A Randomized, Double-Blind, Parallel-Group Comparative Trial
Scientific Title:Acronym
Investigation of the Immunomodulatory Effects of Continuous Consumption of the Test Supplement
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 12 weeks of test supplement consumption on immune function in men and women aged 20 to under 70.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of cell populations using flow cytometry
Quantitative assessment of cytokine responses in PBMCs
Key secondary outcomes
Transcriptome analysis via RNA-seq
Blood proteomics analysis
Quantification of blood lipid concentrations
Health condition questionnaires
Autonomic nervous system evaluation
Cardiovascular risk assessment
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
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of 5 tablets and 1 powder sachet after breakfast (placebo).
Interventions/Control_2
Daily intake of 5 tablets and 1 powder sachet after breakfast (Intervention Group 1: low dose).
Interventions/Control_3
Daily intake of 5 tablets and 1 powder sachet after breakfast (Intervention Group 1: medium dose).
Interventions/Control_4
Daily intake of 5 tablets and 1 powder sachet after breakfast (Intervention Group 1: high dose).
Interventions/Control_5
Daily intake of 5 tablets and 1 powder sachet after breakfast (Intervention Group 2: low dose).
Interventions/Control_6
Daily intake of 5 tablets and 1 powder sachet after breakfast (Intervention Group 2: high dose).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 to under 70 years.
2. Japanese men and women.
3. BMI between 18.5 kg/m^2 and 30.0 kg/m^2.
4. History of at least one upper respiratory tract infection per year.
5. Ability to input data into an electronic diary via smartphone or PC.
6. Voluntary participation with written informed consent after receiving a thorough explanation of the study's purpose and details.
Key exclusion criteria
1. Currently undergoing treatment for any disease with medication or herbal remedies (occasional use allowed).
2. Under medical supervision for dietary or exercise therapy.
3. Current or history of severe diseases.
4. Diagnosed with atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related disorders
5. Consumes yogurt, lactic acid bacteria, or bifidobacteria beverages three or more times per week.
6. Habitually drinks milk (including low-fat milk) three or more times per week.
7. Lactose intolerant
8. Regularly consumes over-the-counter drugs, functional foods, health foods, or supplements three or more times per week (eligible if discontinued after consent acquisition).
9. Received a vaccine for influenza, COVID-19, or other infections within one month prior to the first visit or plans to receive one during the study period.
10. Current or history of drug or food allergies.
11. Irregular lifestyle due to night shifts or rotating shifts.
12. Plans to significantly change lifestyle habits (diet, sleep, exercise, etc.) during the study period.
13. Heavy alcohol consumption (>=40g/day of alcohol).
14. Plans for overseas travel during the study period.
15. Pregnant, breastfeeding, or planning to become pregnant during the study period.
16. Blood donation exceeding 200 mL within one month or 400 mL within three months prior to screening.
17. Participation in another clinical study within one month prior to consent acquisition, currently participating, or planning to participate during the study period.
18. Considered unsuitable for participation by the principal investigator or sub-investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Takada |
Organization
ONO PHARMACEUTICAL CO., LTD.
Division name
Business Design, Business Planning
Zip code
541-8564
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka, 541-8564, Japan
TEL
06-6263-2924
y.takada@ono-pharma.com
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
jimukyoku@imeqrd.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
| 2026 | Year | 10 | Month | 12 | 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
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 12 | 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 | 06 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066441
