UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062635 |
|---|---|
| Receipt number | R000071667 |
| Scientific Title | An exploratory study of the anti-aging effects of test foods: an open-label, randomized, parallel-group comparative trial |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/19 15:06:26 |
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Basic information
Public title
An exploratory study of the anti-aging effects of test foods: an open-label, randomized, parallel-group comparative trial
Acronym
An exploratory study of the anti-aging effects of test foods
Scientific Title
An exploratory study of the anti-aging effects of test foods: an open-label, randomized, parallel-group comparative trial
Scientific Title:Acronym
An exploratory study of the anti-aging effects of test foods
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to clarify age-related physiological changes and evaluate the potential anti-aging effects of the test foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the Plasma Extracellular vesicle (EV) proteome from baseline to Week 8
Key secondary outcomes
1. Changes from baseline to Week 8:
a. T-cell subsets
b. Blood protein levels
c. Salivary protein levels
d. EV morphology
e. Scores on subjective assessment questionnaires
2. Baseline diffrences between younger and older participants:
a. Plasma EV proteome
b. T-cell subsets
c. Blood protein levels
d. Salivary protein levels
e. EV morphology
f. Scores of subjective assessment questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of test food 1 for 8 weeks (older participants)
Interventions/Control_2
Continuous intake of test food 2 for 8 weeks (older participants)
Interventions/Control_3
No intake of test food (older participants)
Interventions/Control_4
No intake of test food (younger participants)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Individuals aged 20 to <30 years or 60 to <75 years at the time of screening.
(2) Japanese men and women.
(3) Individuals with a body mass index (BMI) of >= 18.5 kg/m^2.
(4) Able to complete electronic questionnaires and diaries using a smartphone or personal computer (PC).
(5) Individuals who voluntarily agreed to participate and provided written informed consent after receiving and fully understanding and explanation of the purpose and procedures of the study.
Key exclusion criteria
(1) Current or previous immune-related diseases or other serious medical conditions.
(2) Diagnosis of dry mouth (xerostomia).
(3) Currently receiving dietary therapy or exercise therapy under the supervision of a physician.
(4) Routine consumption (>= 3 times per week) of foods for specified health uses, foods with function claims, dietary supplements containing lactic acid bacteria or bifidobacteria, or other foods or dietary supplements claiming to maintain immune function.
(5) Known allergy to the test food (older adults only).
(6) Planned use during the study period of medications that may affect immune function or the intestinal environment, including antihistamines, antibiotics, intestinal regulators, laxatives, NSAIDs (e.g., loxoprofen and celecoxib), corticosteroids, leukotriene receptor antagonists, PPIs, or hypnotics.
(7) Scheduled to undergo endoscopy, barium gastrointestinal examination, Helicobacter pylori eradication therapy, tooth extraction, ophthalmic surgery, endoscopic procedures, or any other invasive surgery or medical procedure during the study period.
(8) Excessive alcohol consumption (defined as an average daily intake of >= 40 g of pure alcohol).
(9) Excessive smoking (defined as >= 21 cigarettes per day).
(10) Engagement in shift work involving night shifts.
(11) Planned major changes in lifestyle during the study period, including diet, use of health foods or dietary supplements, medications, sleep habits, or physical activity.
(12) Planned overseas travel during the study period.
(13) Pregnant, breastfeeding, or planning to become pregnant during the study period (younger adults only).
(14) Participation in another clinical study within 1 month before providing informed consent, current participation in another clinical study, or planned participation in another clinical study during the study period.
(15) Planned vaccination during the study period.
(16) Deemed unsuitable for participation in the study by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Fukuda |
Organization
Kirin Holdings Company, Limited
Division name
Research & Development division, Kirin Central Research Institute
Zip code
251-8555
Address
Shonan Health Innovation Park, 2-26-1, Muraoka-Higashi, Fujisawa, Kanagawa, Japan
TEL
080-1930-9968
Takafumi_Fukuda@kirin.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
Kirin Holdings Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation, Health and Nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kirin Holdings Company, Ltd.
Address
Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan
Tel
03-6837-7000
02976_Ni@kirin.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
医療法人社団浩央会 東小金井さくらクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 21 | 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 | 07 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 03 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071667
