UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of amino acids mixture during exercise
Title of the study (Brief title)	The effects of amino acids mixture during exercise
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of amino acid mixture with placebo during exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood cortisol
Key secondary outcomes	Questionnaire Blood glucose Blood ACTH Blood CK Blood lactate Blood NH3 Blood free fatty acid Blood total ketone bodies

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Exercise A after ingestion of test product-> Washout-> Exercise A after ingestion of control product-> Washout-> Exercise B after ingestion of test product Washout-> Exercise B after ingestion of control product
Interventions/Control_2	Exercise A after ingestion of control product-> Washout-> Exercise B after ingestion of control product-> Washout-> Exercise A after ingestion of test product Washout-> Exercise B after ingestion of test product
Interventions/Control_3	Exercise B after ingestion of test product-> Washout-> Exercise A after ingestion of test product-> Washout-> Exercise B after ingestion of control product-> Washout-> Exercise A after ingestion of control product
Interventions/Control_4	Exercise B after ingestion of control product-> Washout-> Exercise B after ingestion of test product-> Washout-> Exercise A after ingestion of control product Washout-> Exercise A after ingestion of test product
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	40 years-old >
Gender	Male
Key inclusion criteria	1)Subjects who have given written informed consent 2)Healthy males aged 20 to 39 years old 3)Subjects whose BMI ranges from 18.5 to 25.0 4)Subjects whose blood cortisol increased during exercise at screening
Key exclusion criteria	1)Subjects with food allergies 2) Subjects having a smoking habit 3) Subjects who had blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study 4)Subjects who are currently participating in other clinical studies 5)Subjects who are judged as ineligible by the doctor for other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	Katsuhisa Sakano
Organization	CPCC Company Limited
Division name	Clinical Reserch Planning Department
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Email	k.s@cpcc.co.jp

Public contact
Name of contact person	Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Homepage URL
Email	m.i@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	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）/Chiyoda Paramedical Care Clinic(Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 25 Day
Anticipated trial start date	2016 Year 08 Month 20 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	2016 Year 08 Month 10 Day
Last modified on	2017 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027165