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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name