UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040024 |
|---|---|
| Receipt number | R000045240 |
| Scientific Title | Effects of Combined Intake of Essential Amino Acids and Tea Catechin. |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2022/04/04 09:24:30 |
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Basic information
Public title
Effects of Combined Intake of Essential Amino Acids and Tea Catechin After Exercise on Muscle Mass and Strength of older adults.
Acronym
Effects of Combined Intake of Essential Amino Acids and Tea Catechin After Exercise on Muscle Mass and Strength of older adults.
Scientific Title
Effects of Combined Intake of Essential Amino Acids and Tea Catechin.
Scientific Title:Acronym
Effects of Combined Intake of Essential Amino Acids and Tea Catechin.
Region
| Japan |
Condition
Condition
Geriatric syndrome
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the aim of the our study is to evaluate the effects of combined intake of essential amino acids and tea catechinintake after exersice on increasing muscle mass and physical performance 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
Skeletal muscle mass index, grip strength, knee extension strength, gait speed, Timed up & Go
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake essential amino acids and tea catechins after exercise for 24weeks.
Interventions/Control_2
Intake essential amino acids after exercise for 24weeks.
Interventions/Control_3
Performed exercise for 24weeks.
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
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
Older adults over 65 years old
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
University of Tokushima
Division name
Institute of Advanced Medical Sciences
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima City, Tokushima 770-8503
TEL
0886337587
mori.hiroyasu@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
University of Tokushima
Division name
Institute of Advanced Medical Sciences
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima City, Tokushima 770-8503
TEL
0886337587
Homepage URL
mori.hiroyasu@tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Advanced Medical Sciences, University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
University of Tokushima
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
University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics
Address
2-50-1, Kuramoto-cho, Tokushima City, Tokushima
Tel
088-633-9294
awachiken@tokushima-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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://plaza.umin.ac.jp/~chiken/
Publication of results
Published
Result
URL related to results and publications
https://www.tokushima-u.ac.jp/
Number of participants that the trial has enrolled
124
Results
The pre- to post-intervention increase in skeletal muscle mass was significantly higher in the exercise + amino acid + catechins group than in the exercise group in older adults with sarcopenia.
The pre- to post-intervention increase in skeletal muscle mass was not higher in the exercise + amino acid + catechins group than in the exercise group in healthy older adults without sarcopenia.
Results date posted
| 2022 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sarcopenia measurements were performed on elderly people in Hyogo Prefecture. There were 78 elderly people who did not have sarcopenia. Forty-six elderly subjects had sarcopenia.
Participant flow
Seventy-eight healthy elderly subjects without sarcopenia were randomly assigned to the exercise group, exercise + amino acids group, or exercise + amino acids + catechins group.
Forty-six elderly subjects with sarcopenia were randomly assigned to the exercise group, exercise + amino acids group, or exercise + amino acids + catechins group.
Adverse events
None
Outcome measures
Skeletal muscle mass of extremities, isometric maximal muscle strength, physical function, quality of life, nutritional intake
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045240
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