UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063621 |
|---|---|
| Receipt number | R000072720 |
| Scientific Title | A pilot trial to investigate the effects of lifestyle and dietary supplement interventions on biological age |
| Date of disclosure of the study information | 2026/11/13 |
| Last modified on | 2026/11/13 13:45:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot trial to investigate the effects of lifestyle and dietary supplement interventions on biological age
Acronym
A pilot trial to investigate the effects of lifestyle and dietary supplement interventions on biological age
Scientific Title
A pilot trial to investigate the effects of lifestyle and dietary supplement interventions on biological age
Scientific Title:Acronym
A pilot trial to investigate the effects of lifestyle and dietary supplement interventions on biological age
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of a 4-week lifestyle intervention and a dietary supplement intervention, administered alone and in combination, on the change in AgeGap.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in AgeGap, calculated from biological age, from baseline to 4 weeks after the start of the intervention
Key secondary outcomes
Changes in biological age and pace of aging estimated by published epigenetic clocks (Horvath, Hannum, PhenoAge, GrimAge, GrimAge2, DunedinPACE, etc.) from baseline to 4 weeks after the start of the intervention
Incidence of adverse events associated with the lifestyle and dietary supplement interventions
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Lifestyle intervention plus study supplement (personalized formula) for 4 weeks. The personalized formula consists of the basic formula ingredients with additional personalized ingredients selected based on DNA methylation data.
Interventions/Control_2
Lifestyle intervention same as Group 1, but the study supplement is the basic formula only.
Interventions/Control_3
Lifestyle intervention same as Group 1, but a placebo supplement (containing no active ingredients) is taken instead of the study supplement.
Interventions/Control_4
No lifestyle intervention. Study supplement (personalized formula) same as Group 1.
Interventions/Control_5
No lifestyle intervention. Study supplement (basic formula only) same as Group 2.
Interventions/Control_6
No lifestyle intervention. Placebo supplement same as Group 3.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 61 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who have previously undergone assessment and have a biological age estimated by the Epigenetic AI algorithm, who were aged 40 to 59 years at the time of the previous assessment, and who have an AgeGap, calculated from biological age, of +1 year or greater.
Key exclusion criteria
History of or treatment for cardiovascular disease
Uncontrolled hypertension (resting systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg)
Chest symptoms such as chest tightness during exercise
Recurrent syncope (three or more episodes of loss of consciousness)
History of or treatment for cerebrovascular disease or other serious brain disease
History of or treatment for malignancy
Current or past treatment for diabetes mellitus
Serious liver or kidney disease
Joint pain (e.g., knee or low back pain) or musculoskeletal disorders that interfere with the exercise program
Exercise restricted by a physician
Pregnant or breastfeeding
Use of medications with potential interactions with the study interventions
Use of antidepressants, hypnotics, or other psychotropic drugs
Allergy or other contraindication to the dietary supplements or foods used in this study
Other individuals judged inappropriate for participation, including those with malnutrition
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Hachiya |
Organization
Epigenetic AI Inc.
Division name
R&D
Zip code
105-0003
Address
10F Atagoyama PREX, 3-25-31 Nishi-Shimbashi, Minato-ku, Tokyo 105-0003, Japan
TEL
03-6820-0921
support@epigeneticai.co.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Matsuno |
Organization
Epigenetic AI Inc.
Division name
Business Development Department
Zip code
105-0003
Address
10F Atagoyama PREX, 3-25-31 Nishi-Shimbashi, Minato-ku, Tokyo 105-0003, Japan
TEL
03-6820-0921
Homepage URL
support@epigeneticai.co.jp
Sponsor or person
Institute
Epigenetic AI Inc.
Institute
Department
Personal name
Funding Source
Organization
Mikakuto Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Chiinkai Medical Corporation, Mikakuto Co., Ltd., UHA EJUTECH Co., Ltd.
Name of secondary funder(s)
Epigenetic AI Inc.
IRB Contact (For public release)
Organization
Epigenetic AI Inc. Ethics Review Committee
Address
10F Atagoyama PREX, 3-25-31 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
03-6820-0921
support@epigeneticai.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
医療法人知音会（京都府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blinding applies to the dietary supplement intervention; the lifestyle intervention is open-label.
Management information
Registered date
| 2026 | Year | 11 | Month | 13 | Day |
Last modified on
| 2026 | 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=R000072720
