UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057771 |
|---|---|
| Receipt number | R000066022 |
| Scientific Title | The effects of amino acid and tea catechin intake after exercise on physical function and health-related quality of life in older adults |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/05/03 18:57:12 |
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Basic information
Public title
The effects of amino acid and tea catechin intake after exercise on physical function and health-related quality of life in older adults
Acronym
The effects of amino acid and tea catechin intake after exercise on physical function and health-related quality of life in older adults
Scientific Title
The effects of amino acid and tea catechin intake after exercise on physical function and health-related quality of life in older adults
Scientific Title:Acronym
The effects of amino acid and tea catechin intake after exercise on physical function and health-related quality of life in older adults
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to evaluate the effects of combined intake of essential amino acids and tea catechin intake after exercise on increasing physical performance and QOL among older adults using a randomized controlled design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait speed
Key secondary outcomes
Health related QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake amino acids and tea catechins after exercise.
Interventions/Control_2
Exercise only
Interventions/Control_3
Intake amino acids after exercise.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aged 65 or older, and under 85
Key exclusion criteria
Impaired joint and motor function, diabetes, chronic kidney disease, those who have a pacemaker on the heart, gait dysfunction, those who are restricted from eating or exercising by a doctor,and performed resistance exercise twice a week or more.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Niigata University of Health and Welfare
Division name
Department of Health Science, Department of Health and Nutrition
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
TEL
0252574006
hiroyasu-mori@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Niigata University of Health and Welfare
Division name
Department of Health Science, Department of Health and Nutrition
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
TEL
0252574006
Homepage URL
hiroyasu-mori@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Approval Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
Tel
0252574455
rinri@nuhw.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 | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066022
