UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054344 |
|---|---|
| Receipt number | R000062066 |
| Scientific Title | An exploratory study on the relationship between protein intake in elderly individuals living in a community and plasma albumin redox state, urinary taurine, and urinary trimethylamine N-oxide. |
| Date of disclosure of the study information | 2024/05/11 |
| Last modified on | 2025/04/01 10:07:43 |
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Basic information
Public title
An exploratory study on the relationship between protein intake in elderly individuals living in a community and plasma albumin redox state, urinary taurine, and urinary trimethylamine N-oxide.
Acronym
An exploratory study on the relationship between protein intake in elderly individuals living in a community and plasma albumin redox state, urinary taurine, and urinary trimethylamine N-oxide.
Scientific Title
An exploratory study on the relationship between protein intake in elderly individuals living in a community and plasma albumin redox state, urinary taurine, and urinary trimethylamine N-oxide.
Scientific Title:Acronym
An exploratory study on the relationship between protein intake in elderly individuals living in a community and plasma albumin redox state, urinary taurine, and urinary trimethylamine N-oxide.
Region
| Japan |
Condition
Condition
Malnutrition
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratively investigate the changes in plasma albumin redox state, urinary taurine, and urinary trimethylamine N-oxide resulting from the intake of supplement of high protein-enriched foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in albumin oxidative-reduction balance, urinary taurine, and urinary TMAO levels, along with the consumption status of commercially available protein-fortified foods (3months)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of protein foods
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who understand and agree with the purpose of this study.
Individuals who have not been diagnosed with dementia.
Individuals with 20 or more functional teeth.
Individuals who do not have impaired swallowing function.
Key exclusion criteria
Individuals with deficiencies in the 2011 cohort data from the "Otassha-kenshin" health checkups conducted in the fiscal year 2023.
Individuals with severe systemic illnesses (including past medical history) such as cancer, liver or kidney diseases, digestive disorders, heart diseases, diabetes, neuromuscular disorders, or cerebrovascular disorders.
Individuals using a cardiac pacemaker.
Individuals with serum creatinine levels above 1.2 mg/dL for males or above 1.0 mg/dL for females (based on the 2023 "Otassha-kenshin" health checkup results).
Individuals currently participating in or within 4 weeks of completing participation in other intervention studies, or individuals planning to participate in such studies.
Individuals unable to chew or swallow food.
Other individuals deemed ineligible for inclusion as research subjects by the judgment of a physician or dentist (research collaborator).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Motokawa |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakaecho, Itabashi-ku, Tokyo
TEL
03-3964-3241
kemotokawa@gmail.com
Public contact
Name of contact person
| 1st name | Misato |
| Middle name | |
| Last name | Hayakawa |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakaecho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
kemotokawa@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakaecho, Itabashi-ku, Tokyo
Tel
03-3964-3241
kemotokawa@gmail.com
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 | 05 | Month | 11 | 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
56
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 | 01 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062066
