UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063344 |
|---|---|
| Receipt number | R000072479 |
| Scientific Title | The Effects of Continuous Consumption of the Test Food on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/10/19 18:19:55 |
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Basic information
Public title
The Effects of Continuous Consumption of the Test Food on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
Acronym
The Effects of Continuous Test Food Consumption on Immune Function
Scientific Title
The Effects of Continuous Consumption of the Test Food on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
Scientific Title:Acronym
The Effects of Continuous Test Food Consumption on Immune Function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to evaluate the effects of consuming the test food continuously for 12 weeks on immune parameters in Japanese men and women aged 20 to <65 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical condition questionnaire
Key secondary outcomes
- Comprehensive immune-cell population profiling by mass cytometry, including population and cellular function analyses
- Comprehensive relative quantification of cytokines
- Plasmacytoid dendritic cell (pDC) activity
- Conventional dendritic cell (cDC) activity
<Exploratory outcome>
- Metabolomic analysis
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will take one placebo capsule once daily with water, without chewing, for 12 weeks.
Interventions/Control_2
Participants will take one test food once daily with water, without chewing, for 12 weeks.
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. Aged 20 to <65 years at the time informed consent is obtained
2. Japanese men or women
3. Body mass index (BMI) >=18.5 and <30.0 kg/m^2
4. At least one upper respiratory tract infection per year during the previous 2 years
5. Able to complete an electronic diary using a smartphone or personal computer
6. Has contact with other people at least once per week through work or social activities
7. Has received an adequate explanation of the study objectives and procedures, fully understands them, voluntarily agrees to participate, and provides written informed consent
Key exclusion criteria
1. Current medical treatment for any disease with drugs or Kampo medicines, except as-needed use.
2. Medically supervised diet or exercise therapy.
3. Atopic dermatitis, allergic rhinitis (seasonal/perennial), bronchial asthma, chronic bronchitis, or other immune disorders.
4. Current or past serious disease.
5. Gastrointestinal disease or surgery affecting digestion/absorption, except appendicitis or endoscopically removed colorectal polyps.
6. Inability to stop quasi-drugs, FOSHU, foods with function claims, supplements/health foods, or herbs (e.g., echinacea) from consent to study completion.
7. Known lactose intolerance or excessive abdominal symptoms (e.g., severe diarrhea/bloating) after probiotics/prebiotics.
8. Inability to avoid foods/drinks rich in lactic acid, bifidobacteria, or butyrate-producing bacteria, or unheated fermented foods with live microorganisms, from consent to study completion.
9. Vaccination (e.g., influenza/COVID-19) within 1 month before consent or planned during the study.
10. Planned endoscopy, barium study, H. pylori eradication, or tooth extraction.
11. Oral steroid use within 1 month before consent.
12. Planned regular use of drugs affecting immunity or gut microbiota (e.g., antiallergics, antibiotics, probiotics, laxatives, or immunosuppressants).
13. Current or past drug or food allergy.
14. Excessive alcohol intake (>=40 g/day).
15. Heavy smoking (>=21 cigarettes/day).
16. Shift work including night shifts.
17. Planned major lifestyle changes (diet, sleep, or exercise) during the study.
18. Planned overseas travel during the study.
19. Pregnancy, lactation, or planned pregnancy.
20. Blood donation of 200 mL within 1 month before consent or 400 mL within 3 months before study start.
21. Participation in another clinical study within 1 month before consent, current participation, or planned participation during this study.
22. Deemed unsuitable by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Miyoshi |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2 Minamidai, Kawagoe, Saitama 350-1165, Japan
TEL
049-242-8064
m-miyoshi@meg-snow.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 Building 3F, 6-2-1 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
03-6704-5968
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
医療法人社団浩央会 東小金井さくらクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
| 2026 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2027 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 10 | Month | 19 | Day |
Last modified on
| 2026 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072479
