UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059762 |
|---|---|
| Receipt number | R000068339 |
| Scientific Title | A Study on the Modulation of Aging Clocks Through Exercise |
| Date of disclosure of the study information | 2025/11/14 |
| Last modified on | 2025/11/13 14:20:59 |
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Basic information
Public title
A Study on the Modulation of Aging Clocks Through Exercise
Acronym
A Study on the Modulation of Aging Clocks Through Exercise
Scientific Title
A Study on the Modulation of Aging Clocks Through Exercise
Scientific Title:Acronym
A Study on the Modulation of Aging Clocks Through Exercise
Region
| Japan |
Condition
Condition
Healthy middle-aged men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the effects of long-term exercise training on DNA methylation-based biological aging in healthy middle-aged adults aged 40 to 55 years.
Basic objectives2
Others
Basic objectives -Others
To determine whether regular exercise training is effective in delaying DNA methylation-based biological aging in healthy middle-aged adults aged 40 to 55 years.
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
DNA methylation-based aging clocks
Key secondary outcomes
1. Blood biomarkers 1 (GMM, MME, DMP, DMR, etc.)
2. Blood biomarkers 2 (transcriptome, T cell-derived aging biomarkers, metabolome, plasma copeptin, plasma osmolality, plasma sodium)
3. Gut microbiota (shotgun metagenomics)
4. Morphological parameters (height, body weight, body composition, waist circumference, calf circumference)
5. Physical fitness parameters (Chester step test, handgrip strength, vertical jump)
6. Cognitive function (TMT-A/B, Stroop task, Flanker task, n-back task)
7. Psychological function (WHO QOL-26, POMS2, PSS, K10)
8. Lifestyle factors (PSQI, BDHQ, MEQ, self-administered questionnaire)
9. Urinary indices (urine specific gravity, urine osmolality)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise intervention
Interventions/Control_2
Control
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
| 40 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 40 to 55 years
2. Individuals who are able to participate in a three-month exercise program (three sessions per week) during the study period
3. Individuals with a BMI of 18.5-30.0 kg/m^2
4. Individuals who are able to attend the exercise program three times per week for three months during the study period
5. Individuals who provide written informed consent to participate in the study
Key exclusion criteria
(1) Individuals who are unable to provide informed consent
(2) Individuals who are prohibited from engaging in exercise
(3) Individuals who are currently participating in another clinical study
(4) Individuals deemed otherwise unsuitable for study participation
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai City
TEL
022-717-8824
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Kawamura |
Organization
Tohoku University
Division name
Smart-Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai City
TEL
022-717-8824
Homepage URL
takuji.kawamura.b8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Others
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
Tohoku Certified Review Board of Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
022-718-0461
crp-hosp@grp.tohoku.ac.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
東北大学スマート・エイジング学際重点研究センター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 14 | 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 | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 09 | 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 | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068339
