UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040499 |
|---|---|
| Receipt number | R000046226 |
| Scientific Title | The Longitudinal Study of Resting Energy Expenditure and Nutritional Status for Elderly. |
| Date of disclosure of the study information | 2020/05/23 |
| Last modified on | 2020/12/29 16:24:02 |
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Basic information
Public title
The Longitudinal Study of Resting Energy Expenditure and Nutritional Status for Elderly.
Acronym
The Longitudinal Study of Resting Energy Expenditure and Nutritional Status for Elderly.
Scientific Title
The Longitudinal Study of Resting Energy Expenditure and Nutritional Status for Elderly.
Scientific Title:Acronym
The Longitudinal Study of Resting Energy Expenditure and Nutritional Status for Elderly.
Region
| Japan |
Condition
Condition
Elderly patients
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to calculate an estimation formula for estimating resting energy consumption using indirect calorimetry in elderly Japanese hospitalized patients.
Basic objectives2
Others
Basic objectives -Others
Examining the association between sarcopenia and resting energy expenditure.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Resting energy consumption, as measured by indirect calorimetry.
Key secondary outcomes
Assosiation between limb skeletal muscle mass and resting energy expenditure.
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
| 70 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who have been admitted to Asuke Hospital and who have given consent to participate in this study.
Key exclusion criteria
Under 70 years old.
Those who are not suitable for the test judged by the attending physicians.
example) administering a ventilator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Fumiya |
| Middle name | |
| Last name | Kawase |
Organization
Asuke Hospital Aichi Prefectural Welfare Federation of Agricultural Cooperatives
Division name
Department of Nutrition
Zip code
444-2351
Address
Nakata 20, Yagami-cho, Toyota city
TEL
0565-62-1211
16gn005@st.nuas.ac.jp
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Kawase |
Organization
Asuke Hospital Aichi Prefectural Welfare Federation of Agricultural Cooperatives
Division name
Department of Nutrition
Zip code
444-2351
Address
Nakata 20, Yagami-cho, Toyota city
TEL
0565-62-1211
Homepage URL
16gn005@st.nuas.ac.jp
Sponsor or person
Institute
Asuke Hospital Aichi Prefectural Welfare Federation of Agricultural Cooperatives
Institute
Department
Personal name
Funding Source
Organization
Nagoya University of Arts and Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya University of Arts and Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research management center
Address
Nakata 20, Yagami-cho, Toyota city.
Tel
0565621211
a-hsp@asuke.jaaikosei.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
JA愛知厚生連 足助病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 23 | 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
| 2019 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Test in progress.
Management information
Registered date
| 2020 | Year | 05 | Month | 23 | Day |
Last modified on
| 2020 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046226
