UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055753 |
|---|---|
| Receipt number | R000063719 |
| Scientific Title | Energy Requirements in Patients with Sarcopenia |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2024/10/06 10:43:31 |
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Basic information
Public title
Energy Requirements in Patients with Sarcopenia
Acronym
Energy Requirements in Patients with Sarcopenia
Scientific Title
Energy Requirements in Patients with Sarcopenia
Scientific Title:Acronym
Energy Requirements in Patients with Sarcopenia
Region
| Japan |
Condition
Condition
Patients with Sarcopenia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarification of total energy expenditure in patients with pre-sarcopenia and sarcopenia
Basic objectives2
Others
Basic objectives -Others
To identify background factors in patients with sarcopenia, such as levels of physical functions and blood items related to sarcopenia, intake of various nutrients and physical activity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total energy expenditure under unrestricted living conditions
Key secondary outcomes
Physical function, blood marker levels related to sarcopenia, nutrient intake, and physical activity level
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals aged between 60 and under 85 years old who can provide written informed consent.
Those suspected to have pre-sarcopenia or sarcopenia.
Those who can live independently (able to walk and do household chores alone).
Key exclusion criteria
Individuals unable to undergo cognitive function tests.
Individuals deemed unsuitable by the principal investigator or responsible researcher.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuki |
| Middle name | |
| Last name | Higaki |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
814-0180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
092-871-6631
higaki@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Hatamoto |
Organization
National Institute of Health and Nutrition National Institutes of Biomedical Innovation,
Division name
Department of Nutrition and metabolism
Zip code
5660002
Address
3-17 Senrigaokashinmachi, Settsu, Osaka, 566-0002,1-23-1 Toyama, Shinjuku-ku, Tokyo, 162-8636, Japan
TEL
06-6384-1120
Homepage URL
yhatamoto@nibiohn.go.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
same as above
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
Tel
092-801-1011(3193)
fumed-ethics@fukuoka-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | 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
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
| 2024 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Overview: Energy Expenditure in Sarcopenia Patients Using the Doubly Labeled Water Method
Introduction
Sarcopenia, characterized by the progressive loss of muscle mass and strength, is a significant health issue among older adults. It leads to impaired physical function, reduced quality of life, and increased risks of falls and fractures, often resulting in higher healthcare costs. While nutritional therapy plays a critical role in the prevention and management of sarcopenia, there is limited data on optimal energy intake levels for these patients. This study seeks to address this gap by determining the total energy expenditure (TEE) in pre-sarcopenia and sarcopenia patients using the doubly labeled water (DLW) method, which is the gold standard for measuring energy expenditure in free-living conditions.
Objectives
The primary objective is to clarify the TEE in sarcopenia patients under unrestricted living conditions. Secondary outcomes include exploring relationships between TEE and factors like physical function, nutrient intake, and physical activity.
Study Design
This is a multicenter, observational study conducted across institutions, including Fukuoka University and the National Institute of Health and Nutrition. The study involves participants aged 60 to 85 years who are diagnosed with pre-sarcopenia or sarcopenia. A total of 60 participants will be recruited.
Methods
Doubly Labeled Water (DLW) Method
Participants will consume water labeled with stable isotopes of hydrogen and oxygen. By measuring the rate at which these isotopes are excreted through urine, researchers can accurately calculate the TEE over a 14-day period. This method provides a highly reliable estimate of energy expenditure under real-life conditions.
Management information
Registered date
| 2024 | Year | 10 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063719
