UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of amino acid mixture on exercise performance
Title of the study (Brief title)	Effect of amino acid mixture on exercise performance
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of amino acid mixture on exercise performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Wingate anaerobic performance
Key secondary outcomes	Grip strength Isokinetic leg extension strength Muscle temperature Body temperature Rate of perceived exertion (RPE) Blood lactic acid level Blood glucose level Blood free fatty acid level Blood total ketone body level Blood adrenaline level Blood noradrenaline level Blood dopamine level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food (capsules containing 3,000 mg of amino acid mixture) twice per day for 3 days and exercise on the third day Washout (no less than 6 days) Ingestion of placebo food (capsules not containing amino acid mixture) twice per day for 3 days and exercise on the third day
Interventions/Control_2	Ingestion of placebo food (capsules not containing amino acid mixture) twice per day for 3 days and exercise on the third day Washout (no less than 6 days) Ingestion of test food (capsules containing 3,000 mg of amino acid mixture) twice per day for 3 days and exercise on the third 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	Not applicable
Gender	Male
Key inclusion criteria	1. Persons who give written consent 2. Healthy adults aged 20 years or older 3. Persons capable of endurance exercise
Key exclusion criteria	1. Persons who have any food alergy 2. Persons who have blood drawn (200 mL in the month or 400 mL in the 3 months before the interventions) 3. Persons judged inadequate by the investigator
Target sample size	18

Research contact person
Name of lead principal investigator	Suguru Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5927-3112
Email	s.fujiwara@cpcc.co.jp

Public contact
Name of contact person	Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5927-3112
Homepage URL
Email	m.i@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Food Science Research Laboratories, Meiji Co., Ltd.
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	チヨダパラメディカルケアクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 02 Month 13 Day
Last follow-up date	2017 Year 03 Month 26 Day
Date of closure to data entry	2017 Year 04 Month 24 Day
Date trial data considered complete	2017 Year 04 Month 25 Day
Date analysis concluded	2017 Year 09 Month 14 Day

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

Management information
Registered date	2017 Year 01 Month 26 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029705