UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056159 |
|---|---|
| Receipt number | R000064163 |
| Scientific Title | Investigation of Protein Requirements in Sarcopenia Using the Amino Acid Oxidation Method |
| Date of disclosure of the study information | 2024/11/14 |
| Last modified on | 2024/11/14 17:17:41 |
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Basic information
Public title
Investigation of Protein Requirements in Sarcopenia Using the Amino Acid Oxidation Method
Acronym
Investigation of Protein Requirements in Sarcopenia Using the Amino Acid Oxidation Method
Scientific Title
Investigation of Protein Requirements in Sarcopenia Using the Amino Acid Oxidation Method
Scientific Title:Acronym
Investigation of Protein Requirements in Sarcopenia Using the Amino Acid Oxidation Method
Region
| Japan |
Condition
Condition
Sarcopeia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine the protein requirements in Japanese sarcopenia patients using the indicator amino acid oxidation method
Basic objectives2
Others
Basic objectives -Others
Exploration of Factors Related to Protein Requirements.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
protein requirement
Key secondary outcomes
Protein intake, energy expenditure (physical activity level), and intake of each nutrient
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals capable of providing written informed consent for study participation of their own free will.
Individuals suspected to meet the criteria for pre-sarcopenia or sarcopenia based on the following assessment criteria
Individuals capable of leading an independent lifestyle
Key exclusion criteria
Individuals unable to undergo cognitive function tests
Individuals who have consumed protein supplements at a dosage of 0.5 g/kg or more at least once a week within the past month
Individuals with food allergies to the specified meals provided in the study
Individuals who habitually consume excessive alcohol (pure alcohol intake of 60 g/day or more) or use tobacco regularly
Individuals unable to abstain from smoking and drinking alcohol for three days prior to the IAAO method test day
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hatamoto |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Center for Clinical Nutrition
Zip code
566-0002
Address
NK Building, Kento Innovation Park, 3-17 Senrioka Shinmachi, Settsu City, Osaka Prefecture, Japan
TEL
06-6384-1120
yhatamoto@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Hatamoto |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Center for Clinical Nutrition
Zip code
566-0002
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
National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Hatamoto Yoichi
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
Fukuoka Univ. Department of Bioethics & Medical Ethics
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
Tel
092-801-1011
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
| 2024 | Year | 11 | Month | 14 | 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 | 09 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to elucidate the protein requirements in sarcopenia patients. Protein requirements will be assessed using the indicator amino acid oxidation (IAAO) method, which is considered the gold standard and utilizes the intake of stable isotopes for evaluation.
First, a screening survey will be conducted to select eligible participants. Those deemed eligible will undergo measurements using the IAAO method. The IAAO method involves a dietary intake-based trial using seven test diets with different protein contents, administered once a week over seven weeks (one test diet per day).
Management information
Registered date
| 2024 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064163
