UMIN-CTR Clinical Trial

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
Email	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
Email	mori.hiroyasu@tokushima-u.ac.jp

Sponsor
Institute	Institute of Advanced Medical Sciences, University of Tokushima
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045240