UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of amino acids ingestion on physical fatigue after a single bout of exercise in healthy Japanese.
Title of the study (Brief title)	The effect of amino acids ingestion on physical fatigue after exercise in healthy Japanese.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Hepato-biliary-pancreatic medicine Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effect of amino acids ingestion on physical fatigue and physical function after a single bout of exercise in healthy Japanese.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of physical function, physical fatigue and blood biomarkers for 4 days following a single bout of exercises.
Key secondary outcomes	Questionnaire on physical condition etc. for 4 days following a single bout of exercises.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Intake of amino acids (control) before and after a single bout of lower limbs resistance exercises (30min). The amino acids are also taken twice a day for 3 days after the exercise day. Establish a 3-week washout period. Intake of amino acids (active) before and after a single bout of lower limbs resistance exercises (30min). The amino acids are also taken twice a day for 3 days after the exercise day.
Interventions/Control_2	Intake of amino acids (active) before and after a single bout of lower limbs resistance exercises (30min). The amino acids are also taken twice a day for 3 days after the exercise day. Establish a 3-week washout period. Intake of amino acids (control) before and after a single bout of lower limbs resistance exercises (30min). The amino acids are also taken twice a day for 3 days after the exercise day.
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	20 years-old <=
Age-upper limit	39 years-old >=
Gender	Male
Key inclusion criteria	-A person who hasn't had a motor dysfunction. -A person who is able to participate in a functional fitness test. -A person who hasn't used a cardiac pacemaker and/or an artificial joint.
Key exclusion criteria	-A person who has had severe diseases or the past illness on liver, kidney, heart, lung, digestive organs, blood, endocrine, nerve and metabolic system. -A person who has had severe damage on the locomotive organs such as fracture, tendon rupture, or muscle strain in the past 1 year. -A person who has had dietary allergy. -A person who has had a habit to do strength training. -A person who has been ordered not to do exercise by a medical doctor.
Target sample size	10

Research contact person
Name of lead principal investigator	Yoshihiko Minegishi
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7817
Email	minegishi.yoshihiko@kao.co.jp

Public contact
Name of contact person	Kotaro Tamura
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7687
Homepage URL
Email	tamura.kotaro@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	花王株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 30 Day
Anticipated trial start date	2017 Year 11 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 25 Day
Last modified on	2018 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033946