UMIN-CTR Clinical Trial

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
Email	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
Email	satokonotomi@gmail.com

Sponsor
Institute	Nisikyusyu University Graduate School of Health and Nutrition
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043546