UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063439 |
|---|---|
| Receipt number | R000072431 |
| Scientific Title | Feasibility Study for the Evaluation of Human Aging Markers |
| Date of disclosure of the study information | 2026/10/28 |
| Last modified on | 2026/10/28 09:35:08 |
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Basic information
Public title
Feasibility Study for the Evaluation of Human Aging Markers
Acronym
Feasibility Study for the Evaluation of Human Aging Markers
Scientific Title
Feasibility Study for the Evaluation of Human Aging Markers
Scientific Title:Acronym
Feasibility Study for the Evaluation of Human Aging Markers
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure indicators related to stem cell aging and cellular senescence in PBMCs, plasma proteins, and whole-blood RNA and DNA collected from individuals across a wide range of age groups, and to explore their associations with chronological age, biological age, and physical function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of SA-beta-gal-positive cells
Key secondary outcomes
General Assessments
- Height
- BMI
- Blood pressure
- Pulse rate
- Grip strength
- Total Power
- Body composition
- Body weight
- Body fat mass
- Fat-free mass
- Muscle mass
Hematological Tests
- WBC
- RBC
- Hb
- Ht
- Plt
- MCV
- MCH
- MCHC
- Reticulocyte count
- RDW
- Differential leukocyte count
- Lymphocytes (%)
- Eosinophils (%)
- Basophils (%)
- Neutrophils (%)
- Monocytes (%)
Biochemical Tests
- TP
- Alb
- T-Bil
- GOT (AST)
- GPT (ALT)
- LD
- ALP
- Gamma-GT
- Cr
- UA
- UN
- TG
- TC
- HDL
- LDL
- Na
- Cl
- K
- CRP
- High-sensitivity CRP
- Glu
- HbA1c
Aging-related Tests
- Telomere length [whole blood]
- Telomere length [buccal mucosa]
- p16
- p21
Urinalysis
- Urine protein (qualitative)
- Urine glucose (qualitative)
- Occult blood
- Urobilinogen (qualitative)
- Bilirubin (qualitative)
- Ketone bodies (qualitative)
- pH
- Specific gravity
Subjective Assessments
- SF-36v2
- POMS 2
- Lifestyle assessment (lifestyle habits / menopause-related factors / frailty-related factors / etc.)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy male and female subjects aged 20 years or older and under 80 years at the time of informed consent.
2) Subjects who have fully understood the nature and details of the study and have voluntarily provided written informed consent to participate in the study.
Key exclusion criteria
1) Subjects with a history of psychiatric disorders, diabetes mellitus, hepatic disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious diseases.
2) Subjects who have undergone gastrointestinal surgery, excluding appendectomy.
3) Subjects currently receiving treatment for any disease, or with a history of a serious disease requiring pharmacological treatment.
4) Subjects with autoimmune diseases, such as Graves' disease, rheumatoid arthritis, Hashimoto's thyroiditis, type 1 diabetes mellitus, systemic lupus erythematosus, polymyositis, Sjogren's syndrome, or systemic sclerosis.
5) Subjects with psychiatric disorders (e.g., depression), chronic fatigue syndrome, or insomnia, or a history thereof.
6) Subjects currently receiving treatment, including counseling, for sleep problems, stress, or fatigue.
7) Subjects who are unable to walk independently.
8) Subjects with symptoms of anemia.
9) Subjects who may be at risk of developing an allergic reaction related to the study.
10) Subjects who wish to become pregnant during the study, are pregnant or may be pregnant, or are breastfeeding.
11) Subjects with a history of asthma.
12) Subjects who engage in strenuous sports activities or are currently attempting to lose weight.
13) Subjects whose average daily alcohol intake exceeds 40 g of pure alcohol.
14) Subjects who smoke an average of 21 or more cigarettes per day.
15) Subjects who participated in another clinical trial or clinical study within 12 weeks before informed consent.
16) Subjects who donated whole blood (400 mL within 12 weeks or 200 mL within 4 weeks) or plasma or platelets within 2 weeks before informed consent.
17) Subjects with irregular lifestyles, such as those engaged in night-shift work.
18) Subjects who, after explanation of the study, cannot agree with its purpose.
19) Subjects deemed unsuitable for this study by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Yamada Bee Company, Inc.
Division name
Institute for Bee Products & Health Science
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-1199
ay1255@yamada-bee.com
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Okamoto |
Organization
Yamada Bee Company, Inc.
Division name
Institute for Bee Products & Health Science
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-1199
Homepage URL
ho1993@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
Tel
0868-54-1199
irb@yamada-bee.com
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 | 10 | Month | 28 | 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 | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 10 | Month | 28 | Day |
Last modified on
| 2026 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072431
