UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058758 |
|---|---|
| Receipt number | R000067187 |
| Scientific Title | Exploratory Study on the Geroprotective Effects of a Multi-Domain Lifestyle Intervention (Diet, Physical Activity, Sleep) |
| Date of disclosure of the study information | 2025/08/11 |
| Last modified on | 2025/08/22 08:59:02 |
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Basic information
Public title
Exploratory Study on the Geroprotective Effects of Combined Interventions
Acronym
Exploratory Study on the Geroprotective Effects of Combined Interventions
Scientific Title
Exploratory Study on the Geroprotective Effects of a Multi-Domain Lifestyle Intervention (Diet, Physical Activity, Sleep)
Scientific Title:Acronym
Exploratory Study on the Geroprotective Effects of Diet, Physical Activity and Sleep
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the overall anti-aging effects of multiple interventions targeting diet, physical activity, and sleep on cognitive function, muscle strength, and immune function, and to assess the burden on participants in terms of tolerability and feasibility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive, muscle, and immune function after an 8-week intervention
Key secondary outcomes
Autophagy-related measures; general health checkup parameters; metabolomics, epigenetics, telomere, hormone, and oxidative-stress analyses; sleep and body temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Awa Bancha Autophagy 100 (APGO)
Autophagy Habit NMN25000+ (Mikakuto)
Fine Autophagy ReCell (Fine)
Eating time limit (within 12 hours)
Sleep (7 hours or more)
Exercise (5 days a week, at least one day at the gym)
Interventions/Control_2
No interventions
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
(1) Healthy adults (male and female) aged 50 to 80 years at the time of consent (without any disease related to the study)
(2) Individuals who have received a full explanation of the purpose and content of the study, fully understood the purpose, and voluntarily volunteered to participate and provided written consent to participate in the study.
Key exclusion criteria
(1) Individuals who regularly take specified health foods, functional foods, or health foods (including supplements) at least three times a week and are unable to discontinue use of these foods at the time of consent acquisition (e.g., vitamins A, B, C, D, E, DHA/EPA, sesamin, protein, etc.) that may affect the study.
(2) Individuals who drink a lot of alcohol.
(3) Individuals for whom blood sampling is difficult.
(4) Individuals who have difficulty commuting to the examination site.
(5) Individuals who are unable to perform the exercises required for the examination due to joint or muscular issues.
(6) Individuals with a history or current medical history of serious heart, liver, kidney, or digestive diseases.
(7) Individuals with drug or food allergies.
(8) Individuals who are currently participating in a clinical study of another drug or health food, or who have completed the study within four weeks of the study's completion,
or who plan to participate in another clinical study after agreeing to participate in the current study.
(9) Individuals who have donated blood components or 200 mL of whole blood within one month prior to the start of the study.
(10) Individuals who have donated 400 mL of whole blood within three months prior to the start of the study.
(11) Individuals whose total planned blood collection volume for the study exceeds 1,200 mL when added to the volume of blood collected within 12 months prior to the start of the study.
(12) Individuals who are deemed inappropriate for participation in this study by the principal investigator or co-investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miwako |
| Middle name | |
| Last name | Ishido |
Organization
AutoPhagyGO Inc.
Division name
Management Department
Zip code
565-0871
Address
Office for Industry-University Co-Creation Bldg. A 406, Osaka University, 2-1 Yamadaoka, Suita-shi, Osaka 5650871 Japan
TEL
080-4628-2164
mishido@autophagygo.com
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Ishido |
Organization
AutoPhagyGO Inc.
Division name
Management Department
Zip code
565-0871
Address
Office for Industry-University Co-Creation Bldg. A 406, Osaka University, 2-1 Yamadaoka, Suita-shi
TEL
080-4628-2164
Homepage URL
mishido@autophagygyo.com
Sponsor or person
Institute
AutoPhagyGO Inc.
Institute
Department
Personal name
Funding Source
Organization
AutoPhagyGO Inc.
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
AutoPhagyGO Inc. Ethics Review Committee
Address
Office for Industry-University Co-Creation Bldg. A 406, Osaka University, 2-1 Yamadaoka, Suita-shi
Tel
080-7162-5392
eochi@autophagygo.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
寛友会クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | 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 | 11 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067187
