UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038205 |
|---|---|
| Receipt number | R000043546 |
| Scientific Title | Association between Fraility and Nutritional Status in Institutionalized Older Japanese Adults:Cross-sectional Study |
| Date of disclosure of the study information | 2019/10/04 |
| Last modified on | 2021/02/20 06:54:03 |
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Basic information
Public title
Association between Fraility and Nutritional Status in Institutionalized Older Japanese Adults:Cross-sectional Study
Acronym
Association between Fraility and Nutritional Status in Institutionalized Older Japanese Adults
Scientific Title
Association between Fraility and Nutritional Status in Institutionalized Older Japanese Adults:Cross-sectional Study
Scientific Title:Acronym
Association between Fraility and Nutritional Status in Institutionalized Older Japanese Adults:Cross-sectional Study
Region
| Japan |
Condition
Condition
Frail
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The association between fraility and nutritional status in institutionalized older adults has not been investigated fully.
This study try to explore specific index indicating fraility that can be shared with health workers in nursing home easily.
Basic objectives2
Others
Basic objectives -Others
This study try to investigate the association between fraility and serum vitamin D using the data of nutrient intake and sunlight irradiation time.
The aim of this study is to explore the strategy to improvement of fraility through food services and everyday life in nursing home.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
BMI
Key secondary outcomes
Serum biomarkers(Total Protein,Albmin,Serum 25(OH)vitamin D),MNA-SF score,Sunlight irradiation time,Polypharmacy,Nutrient intake
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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Institutionalized Older Japanese Adults
Key exclusion criteria
Acute disease
Severe disease
Severe cognitive impairment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Kuno |
Organization
Nisikyusyu University
Division name
Graduate School of Health and Nutrition
Zip code
842-8585
Address
4490-9,Ozaki Kanzaki town,Kanzaki city,Saga prefecture
TEL
0952-37-9228
kunok@nisikyu-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Notomi |
Organization
Nisikyusyu University
Division name
Graduate School of Health and Nutrition
Zip code
842-8585
Address
4490-9,Ozaki Kanzaki town,Kanzaki city,Saga prefecture
TEL
0952-37-9228
Homepage URL
satokonotomi@gmail.com
Sponsor or person
Institute
Nisikyusyu University
Graduate School of Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Nisikyusyu University
Private University Research Branding Project "Dementia prevention programe"
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nisikyusyu University Ethics Committee
Address
4490-9,Ozaki Kanzaki town,Kanzaki city,Saga prefecture
Tel
0952-52-4191
syomu@nisikyu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
19FBR15
Org. issuing International ID_1
Nisikyusyu University Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 04 | 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
16
Results
The participants were classified into 2 groups.
The item that showed a significant difference between the two groups was age, Serum total protein, serum albumin. There was no significant difference between the two groups in other items.
The intake of nutrients including vitamin D generally met the dietary intake standards, but the blood 25 (OH) vitamin D level was low in both groups. The frequency of going out was not at all except for one person.
Results date posted
| 2020 | Year | 10 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
Institutionalized elderly persons aged 60 and over in Saga City
Participant flow
Eighteen people were selected, excluding those with serious illness (heart disease, liver disease, etc.), inability to walk (bedridden, wheelchair use, etc.), and severe cognitive impairment, and finally consent was obtained from 17 people. ..
Since there was only one male, only 16 females were included in the analysis, considering the effect of gender differences on the results.
Adverse events
None
Outcome measures
BMI
"Yubi-Wakka test"
Blood test (total protein, albumin, 25 (OH) vitamin D)
Nutrient intake
MNA-SF
Number of drugs taken
Frequency of going out
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subjects are divided into 3 groups(frail,pre-frail,non-frail)according to the scores of frail index(Short Form).This study investigate the significant differences between the 3 groups.
Especially, this study investigate the association between frail and serum vitamin D considering the data of nutrient intake and sunlight irradiation time.
The aim of this study is to explore the strategy to improvement of fraility through food services and everyday life in nursing home.
Management information
Registered date
| 2019 | Year | 10 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043546
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