UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058901 |
|---|---|
| Receipt number | R000067349 |
| Scientific Title | Effects of a Multimodal Lifestyle Intervention on Physical, Immune, and Cognitive Functions: A Prospective Interventional Study in Adults |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/26 15:34:33 |
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Basic information
Public title
Effects of a Multimodal Lifestyle Intervention on Physical, Immune, and Cognitive Functions: A Prospective Interventional Study in Adults
Acronym
Multimodal Lifestyle Intervention and Its Impact on Physical, Immune, and Cognitive Functions
Scientific Title
Effects of a Multimodal Lifestyle Intervention on Physical, Immune, and Cognitive Functions: A Prospective Interventional Study in Adults
Scientific Title:Acronym
Multimodal Lifestyle Intervention Effects on Physical, Immune, and Cognitive Functions
Region
| Japan |
Condition
Condition
Adults who are independent in activities of daily living
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to conduct an 8-week lifestyle intervention program for adults (both men and women, aged 50 to 80 years) who are independent in activities of daily living. The program will combine dietary guidance, fasting, exercise, supplementation, yoga, cognitive training, and thermal therapy. The objective is to comprehensively evaluate its efficacy and safety. Specifically, efficacy will be assessed in terms of physical function, cognitive function, immune function, and aging-related biomarkers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical Function:
Cardiopulmonary exercise testing (peak VO2)
Knee extension strength
Muscle mass by urinary D3-creatine dilution method (CT, MRI, DXA)
Cognitive Function:
Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition): executive function, attention, processing speed, and memory
Immune Function:
Ex vivo naive immune responses
IMM-AGE score
CD4+:CD8+ ratio
Lymphocyte-to-neutrophil ratio
Multiplex assays including the SASP Index
Aging-related Biomarkers:
Epigenetic clocks
Telomere length
Mosaic loss of chromosome Y (mLOY)
Key secondary outcomes
Proteomic analysis
RNA sequencing (RNA-seq)
Personal Health Record (PHR)
Continuous glucose monitoring
Clinical data
Body composition
Electroencephalography (EEG)
Gut microbiota analysis
Handgrip strength
Locomotive function test or Five-times Sit-to-Stand test
Gait speed measurement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
An 8-week lifestyle modification intervention program, consisting of dietary guidance, fasting, exercise, supplementation, yoga, cognitive training, and thermal therapy, will be provided to individuals who voluntarily wish to participate. By assessing each outcome measure before and after the program, changes in muscle strength, cognitive function, immune function, and biological aging markers will be analyzed.
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
| 50 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women who are independent in activities of daily living will be eligible.
Key exclusion criteria
systemic infection; acute or chronic viral hepatitis; poorly controlled diabetes mellitus; severe renal or hepatic dysfunction; serious cardiovascular or cerebrovascular disease within the past 6 months; presence of a pacemaker; severe gastrointestinal disease or gastrointestinal surgery within the past 12 months; active malignancy within the past 5 years; current pregnancy or planned pregnancy; and breastfeeding.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Horie |
Organization
Juntendo University Hospital
Division name
department of Urology
Zip code
113-0033
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
y-ikehata@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ikehata |
Organization
Juntendo University Hospital
Division name
department of Urology
Zip code
113-0033
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
y-ikehata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Selg corporation.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital Clinical Research and Trial Center
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3830-3704
jcrtc_operation@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 01 | 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
| 2025 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | 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 | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067349
