UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063268 |
|---|---|
| Receipt number | R000072365 |
| Scientific Title | Evaluation of the relationship between nutritional and lifestyle factors and aging |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/10/14 09:39:07 |
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Basic information
Public title
Evaluation of the relationship between nutritional and lifestyle factors and aging
Acronym
Evaluation of the relationship between nutritional and lifestyle factors and aging
Scientific Title
Evaluation of the relationship between nutritional and lifestyle factors and aging
Scientific Title:Acronym
Evaluation of the relationship between nutritional and lifestyle factors and aging
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the relationship between nutritional and lifestyle factors and aging.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between nutritional and lifestyle factors and aging
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Healthy Japanese men aged 40 to 69 years.
(2) Subjects who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and who have provided written informed consent.
Key exclusion criteria
(1) Subjects who have a disease requiring treatment such as pharmacotherapy, or who have a history of a serious disease requiring surgery or other major medical intervention.
(2) Subjects with a BMI of less than 18.5 or 25.0 higher.
(3) Subjects who have a habit of excessive alcohol consumption or excessive exercise.
(4) Subjects who have extreme dietary habits (e.g. vegetarian, fish-only, or meat-only diets).
(5) Subjects who have had COVID-19 within the last 1 year, or who continue to experience symptoms following COVID-19 infection.
(6) Subjects who currently smoke conventional cigarettes, heated tobacco products (e.g. IQOS), or electronic cigarettes (e.g. VAPE), or who have smoked within the last 6 months.
(7) Subjects who have participated in another clinical study and received an investigational product within 1 month prior to providing informed consent.
(8) Subjects who are unable to provide voluntary informed consent.
(9) Other subjects deemed unsuitable for the study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akihisa |
| Middle name | |
| Last name | Morito |
Organization
Taisho Pharmaceutical Co., Ltd.
Division name
SELF-MEDICATION RESEARCH CENTER
Zip code
331-9530
Address
403, Yoshinocho 1-chome, Kita-Ku, Saitama City, Saitama Prefecture, Japan
TEL
048-669-3048
sm-pharma@taisho.co.jp
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Morito |
Organization
Taisho Pharmaceutical Co., Ltd.
Division name
SELF-MEDICATION RESEARCH CENTER
Zip code
331-9530
Address
403, Yoshinocho 1-chome, Kita-Ku, Saitama City, Saitama Prefecture, Japan
TEL
048-669-3048
Homepage URL
sm-pharma@taisho.co.jp
Sponsor or person
Institute
Taisho Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics Committee of Taisho Pharmaceutical Co., Ltd.
Address
403, Yoshinocho 1-chome, Kita-Ku, Saitama City, Saitama Prefecture, Japan
Tel
048-663-1111
taisho-irb@taisho.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
株式会社SOUKEN（東京）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of the relationship between nutritional and lifestyle factors and aging
Management information
Registered date
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072365
