UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059306 |
|---|---|
| Receipt number | R000067759 |
| Scientific Title | A study to investigate the effects of consuming the test products on immune function: -a randomized, double-blind, placebo-controlled, parallel-group comparison trial- |
| Date of disclosure of the study information | 2025/10/07 |
| Last modified on | 2025/10/06 14:44:10 |
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Basic information
Public title
A study to investigate the effects of consuming the test products on immune function.
Acronym
A study to investigate the effects of consuming the test products on immune function.
Scientific Title
A study to investigate the effects of consuming the test products on immune function: -a randomized, double-blind, placebo-controlled, parallel-group comparison trial-
Scientific Title:Acronym
A study to investigate the effects of consuming the test products on immune function.
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of test products on immune function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
NK cell activity
Key secondary outcomes
- Changes in NK cell activity
- pDC activity and its changes, and the rate of change
- Cumulative days with upper respiratory tract infection (URTI) per individual, and cumulative days by severity for each individual
- Cumulative score for each symptom of URTI per individual
- Cumulative days with URTI symptoms in each group, and cumulative days by severity for each group
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test product: Test food
Interventions/Control_2
Duration: 12 weeks
Test product: Placebo food
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) Healthy Japanese men and women aged 20 years or older and under 65 years old at the time of consent
2) Individuals who are aware that they are susceptible to colds and influenza
3) Individuals who have received a full explanation of the purpose and content of this study, are competent to consent, fully understand the contents, and voluntarily volunteer to participate, and who provide written consent to participate in this study.
Key exclusion criteria
1) Suffering from or currently undergoing treatment for serious diseases such as diabetes, kidney disease, liver disease, or heart disease, thyroid disease, adrenal gland disease, psychiatric disease, autoimmune disease, or other metabolic diseases
2) Chronic diseases and regular medication use
3) Atopic dermatitis, bronchial asthma, or chronic bronchitis
4) Planning to visit a doctor or take prescription medication annually for hay fever or allergic rhinitis
5) History or current history of drug or alcohol dependence
6) History of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption
7) Unable to stop taking supplements or health foods that may affect their immune system during the study period
8) Smoking habit
9) Excessive alcohol consumption
10) Unable to stop taking alcohol for two days prior to the screening test or any other test
11) Declared a food allergy to any component of the study products
12) Day-night shift workers, late-night workers, workers who work from home, and workers engaged in physical labor such as transporting heavy objects
13) Pregnant, intend to become pregnant during the study period, or breastfeeding
14) Unsuitable for study participation based on the blood test results of the screening test
15) Scheduling to receive vaccinations for infectious diseases from one month prior to the screening test until the end of the 12-week test after the start of intake.
16) Scheduling to travel abroad during the study period.
17) Taken antibiotics within one month prior to the screening test.
18) Drawn or donated more than 200 mL of blood within one month or more than 400 mL within three months prior to the consent date.
19) Currently participating in or intend to participate in the trials involving the intake of other foods or pharmaceuticals, or the application of cosmetics.
20) Judged unsuitable for study participation by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
ITO EN, LTD.
Division name
Central Research Institute
Zip code
421-0516
Address
21, Mekami, Makinohara-city, Shizuoka, Japan
TEL
0548-54-1247
m-kobayasi@itoen.co.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Tanaka |
Organization
ITO EN, LTD.
Division name
Central Research Institute
Zip code
421-0516
Address
21, Mekami, Makinohara-city, Shizuoka, Japan
TEL
0548-54-1247
Homepage URL
ya-tanaka@itoen.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
ITO EN, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Maebashi North Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17, Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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 前橋北病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 07 | 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 | 24 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 30 | 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 | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067759
