UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055741 |
|---|---|
| Receipt number | R000063697 |
| Scientific Title | The protein Requirements using amino acid oxidation methods in Older Adult Females. |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/04/22 16:57:21 |
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Basic information
Public title
The protein Requirements using amino acid oxidation methods in Older Adult Females.
Acronym
The protein Requirements using amino acid oxidation methods in Older Adult Females.
Scientific Title
The protein Requirements using amino acid oxidation methods in Older Adult Females.
Scientific Title:Acronym
The protein Requirements using amino acid oxidation methods in Older Adult Females.
Region
| Japan |
Condition
Condition
Female Older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the protein requirements in elderly Japanese women using the indicator amino acid oxidation (IAAO) method.
Basic objectives2
Others
Basic objectives -Others
Protein Requirements in Elderly Japanese Women Using the IAAO Method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of protein requirements in elderly Japanese women using the IAAO method (after 7 trials using the IAAO method).
Key secondary outcomes
Protein intake, energy expenditure, nutrient intake, and changes in skeletal muscle mass (measured during the study period).
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
| 65 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 65 to 80 years
BMI between 18.5 and 30
Stable body weight (no changes of +/-2 kg in the past 6 months)
Willing and able to consume the provided food and beverages
Leading an independent lifestyle (capable of walking and doing household chores independently)
Key exclusion criteria
Individuals with chronic or acute diseases affecting protein or amino acid metabolism (except for controlled hypertension)
Individuals taking regular medication (e.g., diabetes treatment, alpha-blockers, beta-blockers)
Individuals with a history of gastrointestinal surgery (appendectomy is acceptable)
Individuals with extremely irregular eating habits
Individuals participating in other trials during the study period
Individuals allergic to the provided diet
Individuals with excessive alcohol or tobacco use
Target sample size
18
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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 31 | 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
This study targets elderly Japanese women to evaluate protein requirements using the indicator amino acid oxidation (IAAO) method. The assessment of physical activity levels and protein requirements will be conducted using two gold standard methods: the doubly labeled water (DLW) method and the IAAO method, both utilizing stable isotope intake. Initially, a screening survey will be conducted to select participants. Afterward, the total energy expenditure will be quantified using the DLW method. Following the completion of DLW measurements, the IAAO method will be used. The IAAO method involves a seven-week dietary intervention, wherein participants will consume meals with varying protein content across seven levels. This test will be conducted once a week (one level per day) over a seven-week period. One participant will undergo seven conditions with varying protein intake levels (0.1g/kg to 1.8g/kg), each conducted with a washout period of 5-7 days. For example, the test meals with varying protein intake levels (0.1, 0.3, 0.6, 0.9, 1.2, 1.5, 1.8 g/kg) will be administered randomly. On the test day, participants will consume meals containing test proteins at one-hour intervals, along with 13C-Phe, and exhaled breath samples will be intermittently collected in special breath bags. The 13C-Phe analysis will be conducted using infrared spectroscopy or mass spectrometry to measure the concentration of 13CO2 in the breath.
Management information
Registered date
| 2024 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063697
