UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059384 |
|---|---|
| Receipt number | R000067920 |
| Scientific Title | A Study on the Effects of Continued Consumption of the Test Food on Immune and Aging Markers - Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison - |
| Date of disclosure of the study information | 2025/10/25 |
| Last modified on | 2025/10/14 10:34:35 |
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Basic information
Public title
A Study on the Effects of Continued Consumption of the Test Food on Immune and Aging Markers
Acronym
A Study on the Effects of Continued Consumption of the Test Food on Immune and Aging Markers
Scientific Title
A Study on the Effects of Continued Consumption of the Test Food on Immune and Aging Markers
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison -
Scientific Title:Acronym
A Study on the Effects of Continued Consumption of the Test Food on Immune and Aging Markers
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous intake of the test food on immune and aging markers in adult men and women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Health status questionnaire
-Aging markers
Key secondary outcomes
-Immune function-related biomarkers
-Gut microbiota
-QOL Questionnaire
-Physical examination
-Incidence of adverse events and side effects
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
The test food is taken every day.
Interventions/Control_2
The placebo food is taken every day.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age 20 to under 70
2. Japanese men and women
3. BMI >=18.5 kg/m^2 and <30.0 kg/m^2
4. History of at least one upper respiratory tract infection per year
5. Regular contact with others at least once a week through work or social activities
6. Ability to enter electronic diaries via smartphone or PC
7. Received thorough explanation of study purpose and content, fully understood, voluntarily consented to participate, and provided written informed consent
Key exclusion criteria
1. Currently receiving outpatient treatment for any disease or taking medication, including Kampo (as-needed use permitted)
2. Under physician-supervised dietary or exercise therapy
3. Current or past history of serious illness
4. Atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related disorders
5. Consumes yogurt, lactic acid bacteria, or bifidobacteria-containing foods three or more times per week
6. Regular use (three or more days per week) of over-the-counter drugs, quasi-drugs, specified health foods, supplements, or unwillingness to refrain from starting new intake during the study
7. Vaccinated against influenza, COVID-19, or other infections within one month prior to first visit, or plans to be vaccinated during the study
8. Plans to use medications affecting immune function or gut environment (e.g., anti-allergy drugs, antibiotics, probiotics, laxatives) during the study
9. Scheduled for endoscopy, barium examination, or H. pylori eradication during the study
10. Current or past drug or food allergies
11. Irregular lifestyle due to night shifts or rotating shifts
12. Plans to significantly change lifestyle habits (diet, sleep, exercise, etc.) during the study
13. Excessive alcohol consumption (>=40g pure alcohol per day)
14. Plans for overseas travel during the study
15. Pregnant, breastfeeding, or planning pregnancy during the study
16. Blood donation of >200ml within 1 month or >400ml within 3 months prior to screening
17. Participation in another clinical study within 1 month prior to consent, currently participating, or planning to participate during the study
18. Deemed unsuitable for participation by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Abe |
Organization
TAIYO KAGAKU CO., Ltd.
Division name
NUTRITION DIVISION
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichi, Mie, JAPAN
TEL
059-347-5411
aabe@taiyokagaku.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
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
TAIYO KAGAKU 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
| 2025 | Year | 10 | Month | 25 | 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 | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 13 | 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 | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067920
