UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059504 |
|---|---|
| Receipt number | R000067859 |
| Scientific Title | Evaluation of the efficacy of continuous consumption of the study food on immune function - A randomized, placebo-controlled, double-blind, parallel-group study - |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/10/07 19:00:11 |
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Basic information
Public title
Evaluation of the efficacy of continuous consumption of the study food on immune function
- A randomized, placebo-controlled, double-blind, parallel-group study -
Acronym
Evaluation of the efficacy of continuous consumption of the study food on immune function
Scientific Title
Evaluation of the efficacy of continuous consumption of the study food on immune function
- A randomized, placebo-controlled, double-blind, parallel-group study -
Scientific Title:Acronym
Evaluation of the efficacy of continuous consumption of the study food on immune function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of four weeks of study food intake 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, blood levels of 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 one 65 mL bottle of the test beverage once each morning
Interventions/Control_2
Consume one 65 mL bottle of the placebo beverage once each morning
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. History of upper respiratory tract infection at least once a year
5. BMI 18.5 or more, and less than 30.0 kg/m^2
6. Able to enter electronic diaries via smartphone or PC
7. Received thorough explanation of study purpose and details, fully understood, voluntarily agreed to participate, and provided written consent
Key exclusion criteria
1. Currently receiving outpatient treatment or medication (including herbal medicine) for any illness (as-needed use permitted)
2. Under physician-supervised dietary or exercise therapy
3. Current or past history of serious disease
4. 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 (eligible if discontinued after consent)
7. Lactose intolerance
8. Received vaccination for influenza, COVID-19, etc., within one month before screening visit, or plans to be vaccinated during study period
9. Current or past history of drug or food allergies
10. Irregular lifestyle due to night shifts or other shift work
11. Plans to significantly change lifestyle habits (diet, sleep, exercise, etc.) during study period
12. Excessive alcohol consumption (>=40 g pure alcohol per day)
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 | Hiroyuki |
| 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,Shinjuku-ku,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
| 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 02 | 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 | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067859
