UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062965 |
|---|---|
| Receipt number | R000072093 |
| Scientific Title | Evaluation of the efficacy of 8-week continuous intake of the study food on immune function - A randomized, placebo-controlled, double-blind, parallel-group study - |
| Date of disclosure of the study information | 2026/09/22 |
| Last modified on | 2026/09/17 17:09:31 |
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Basic information
Public title
Evaluation of the efficacy of 8-week continuous intake of the study food on immune function
Acronym
Evaluation of the efficacy of 8-week continuous intake of the study food on immune function
Scientific Title
Evaluation of the efficacy of 8-week continuous intake of the study food on immune function
- A randomized, placebo-controlled, double-blind, parallel-group study -
Scientific Title:Acronym
Evaluation of the efficacy of 8-week continuous intake of the study food on immune function
- A randomized, placebo-controlled, double-blind, parallel-group study -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of 8-week intake of the study food on immune function in men and women aged 20 to under 60 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire regarding physical condition
Key secondary outcomes
Immune cell analysis using mass cytometry, comprehensive relative quantification of blood cytokines
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
Consume four capsules of the study food once daily after breakfast for 8 weeks.
Interventions/Control_2
Consume four capsules of the placebo food once daily after breakfast for 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 to under 60 years
2. Japanese men and women
3. Have contact with others at least once a week through work or social activities
4. Have had an upper respiratory tract infection at least once a year
5. BMI of 18.5 or more and less than 30.0 kg/m^2
6. Able to enter electronic diary data via smartphone or PC
7. Received thorough explanation of the study, understand its purpose and content, voluntarily agreed to participate, and provide written informed consent
Key exclusion criteria
1. Currently receiving outpatient treatment for any illness or taking medications, including Kampo (as-needed use permitted)
2. Under physician-supervised dietary or exercise therapy
3. Current or past history of serious diseases
4. Have atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related disorders
5. Consuming yogurt or foods containing lactic acid bacteria or bifidobacteria (eligible if discontinued after consent)
6. Currently taking quasi-drugs, Foods for Specified Health Uses, health foods, or supplements (participation allowed if discontinued after consent and during the study)
7. Lactose intolerance
8. Received vaccination for influenza, COVID-19, or similar infections within one month before screening, or plan to be vaccinated during the study
9. Current or past history of drug or food allergies
10. Habitual excessive alcohol consumption (>=40g pure alcohol/day)
11. Habitual excessive smoking (>=21 cigarettes/day)
12. Irregular lifestyle due to night shifts or rotating shifts
13. Plan to significantly change lifestyle habits (diet, sleep, exercise, etc.) during the study
14. Plan to travel abroad during the study
15. Pregnant, breastfeeding, or planning to become pregnant during the study
16. Blood donation of over 200 mL within 1 month or over 400 mL within 3 months prior to consent
17. Participation in another clinical study within 1 month before consent, currently participating, or planning to participate during the study
18. Deemed unsuitable for participation by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Fukao |
Organization
NISSIN YORK CO., LTD.
Division name
Development Laboratories
Zip code
348-8549
Address
272 Kamimurakimi, Hanyu, Saitama, Japan
TEL
048-565-4686
masanori.fukao@nissin.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo 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
NISSIN YORK 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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 05 | 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 | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072093
