UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055132 |
|---|---|
| Receipt number | R000060540 |
| Scientific Title | Examination of blood molecules related to health with high well-being in healthy elderly |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/01/31 09:42:17 |
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Basic information
Public title
Examination of blood molecules related to health with high well-being in healthy elderly
Acronym
Examination of blood molecules related to health with high well-being in healthy elderly
Scientific Title
Examination of blood molecules related to health with high well-being in healthy elderly
Scientific Title:Acronym
Examination of blood molecules related to health with high well-being in healthy elderly
Region
| Japan |
Condition
Condition
Non
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the molecules in blood that contribute to increased well-being, through intervention studies,
Basic objectives2
Others
Basic objectives -Others
Non
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Well-being
2)Blood sampling
Key secondary outcomes
1)Cognitive function test
2)Physical function test
3)Daily physical activity evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Promoting daily physical activities
Interventions/Control_2
Well-being therapy
Interventions/Control_3
Control
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age: over 65 years
MMSE-J score: over 25 points
GLFS-25 score: under 16 points
No history of cognitive or motor dysfunction due to cerebrovascular disease, etc.
Have the ability to understand and agree to the terms of the consent form on their own.
Key exclusion criteria
Have withdrawn their consent after completion of participation in the study.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yuna |
| Middle name | |
| Last name | Inada |
Organization
University of Toyama
Division name
Institute of Natural Medicine
Zip code
9300194
Address
2630 Sugitani, Toyama
TEL
0764347670
yuna@inm.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yuna |
| Middle name | |
| Last name | Inada |
Organization
University of Toyama
Division name
Institute of Natural Medicine
Zip code
9300194
Address
2630 Sugitani, Toyama
TEL
0764347670
Homepage URL
yuna@inm.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama University Hospital, Center for Clinical and Translational Research
Address
2630 Sugitani Toyama
Tel
0764347154
tymshien@med.u-toyama.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
| 2024 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | 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
Management information
Registered date
| 2024 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060540
