UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058745 |
|---|---|
| Receipt number | R000066893 |
| Scientific Title | A Study on the Immunostimulatory Effects of the Test Food -A Randomized, Double-blind, Parallel-group Study- |
| Date of disclosure of the study information | 2025/08/19 |
| Last modified on | 2025/08/21 23:51:14 |
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Basic information
Public title
A Study on the Immunostimulatory Effects of the Test Food -A Randomized, Double-blind, Parallel-group Study-
Acronym
A Study on the Immunostimulatory Effects of the Test Food
Scientific Title
A Study on the Immunostimulatory Effects of the Test Food -A Randomized, Double-blind, Parallel-group Study-
Scientific Title:Acronym
A Study on the Immunostimulatory Effects of the Test Food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the test food on immune function, primarily IgA, in healthy adults for eight weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary s-IgA concentration
Key secondary outcomes
- Questionnaire on cold-like symptoms
- Fecal IgA concentration
- IgA antibody titer (Influenza A)
- Immune function assessment (T cell count, CD4 T cell count, CD8 T cell count, CD4/CD8 ratio, naive T cell count, memory T cell count, naive/memory ratio, CD8+CD28+ T cell count, B cell count, NK cell count, immune score, T lymphocyte age)
- Salivary tests (cortisol, DHEA, oxytocin)
- Blood tests (BAP, d-ROM)
- Gut microbiota
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
Consumption of the test food (1 pack a day, 8 weeks)
Interventions/Control_2
Consumption of the placebo food (1 pack a day, 8 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. Participants aged 20 to 64 years
2. Japanese men and women
3. BMI over 18.5 and less than 30.0 kg/m^2
4. History of upper respiratory tract infection at least once per year
5. Able to enter electronic diaries via smartphone or PC
6. Sufficiently informed about the study and voluntarily consented in writing
Key exclusion criteria
1. Currently receiving treatment for any disease with medication or Kampo (as-needed use allowed)
2. Under physician-supervised dietary or exercise therapy
3. History or presence of serious illness
4. History of gastrointestinal surgery (except appendicitis)
5. Atopic dermatitis, allergic rhinitis (seasonal/perennial), bronchial asthma, chronic bronchitis, or other immune-related diseases (e.g., autoimmune diseases)
6. Current or past treatment for dry mouth or Sjogren's syndrome
7. Consumes yogurt, lactic acid bacteria, or bifidobacteria foods at least 3 times per week, or unwilling to refrain during the study
8. Currently taking quasi-drugs, FOSHU, FFC, supplements, or health foods (allowed if discontinued after consent)
9. Plans to use drugs affecting immune function or gut flora (e.g., antiallergics, antibiotics) during the study
10. Vaccinated against influenza, COVID-19, etc., within 1 month before consent, or plans to be vaccinated during the study
11. Participants with current or past drug or food allergies
12. Irregular lifestyle due to night or shift work
13. Plans to significantly change lifestyle (diet, sleep, exercise) during the study
14. Heavy alcohol consumption (more than or equal to 40 g per day)
15. Excessive smoking (more than or equal to 21 cigarettes per day)
16. Plans for overseas travel during the study
17. Pregnant, breastfeeding, or planning pregnancy during the study
18. Currently using or planning to use oral contraceptives during the study
19. Donated more than 200 mL of blood within 1 month or more than 400 mL within 3 months before consent
20. Participated in other clinical studies within 1 month before consent, currently participating, or planning to participate during the study
21. Considered unsuitable for participation by the principal or sub-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mamiko |
| Middle name | |
| Last name | Kohno |
Organization
Morishita Jintan Co., Ltd.
Division name
Fundamental Research and Development Department, Research and Development Headquarters
Zip code
573-0128
Address
2-11-1, Tsudayamate, Hirakata-shi, Osaka, 573-0128, Japan
TEL
072-800-1044
m_kohno@jintan.co.jp
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
Morishita Jintan 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
| 2025 | Year | 08 | Month | 19 | 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
| 2025 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066893
