UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054310 |
|---|---|
| Receipt number | R000062037 |
| Scientific Title | Survey of dietary intake and measurement of skin carotenoid density in residents of assisted living facility for the elderly |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/11/01 13:14:54 |
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Basic information
Public title
Survey of dietary intake and measurement of skin carotenoid density in residents of assisted living facility for the elderly
Acronym
Survey of dietary intake and measurement of skin carotenoid density in residents for the elderly
Scientific Title
Survey of dietary intake and measurement of skin carotenoid density in residents of assisted living facility for the elderly
Scientific Title:Acronym
Survey of dietary intake and measurement of skin carotenoid density
Region
| Japan |
Condition
Condition
healthy old people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the relationship between dietary habits and skin carotenoid levels. Additionally, examining the relationship between skin carotenoid levels and health screening results. Based on these findings, estimating desirable levels of skin carotenoids for maintaining health and identifying dietary habits necessary to achieve these levels.
Basic objectives2
Others
Basic objectives -Others
Estimating desirable levels of skin carotenoids for maintaining health and identifying dietary habits necessary to achieve these levels.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
skin carotenoid level
Key secondary outcomes
Nutrient intake level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
dietary education
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Residents of the Hamanako Eden nursing home with care service
2. Individuals who wish to participate in this study voluntarily
3. Those who have provided written consent
4. Age and gender are noy a restriction
5. Individuals deemed eligibility by the examiners
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Eye center
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-474-2222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Mitsuo |
| Middle name | |
| Last name | Kimata |
Organization
Seirei Hamamatsu General Hospital
Division name
Clinical research center
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-474-2222
Homepage URL
m-kimata@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Seirei Hamamatsu General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN), Tokoha University, Faculty of Health Production, Doshisha Women's University, Faculty of Human life Sciences, National Center for Geriatrics and Gerontology (NCGG), Hamanako Eden Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
0534742222
m-kimata@sis.seirei.or.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
浜名湖エデンの園（静岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 31 | 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
40
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
| 2024 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | 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 | 05 | Month | 02 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062037
