UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of fat metabolism by amino acids mixture during exercise on obesity men : a randomized, double-blind, placebo-controlled study
Title of the study (Brief title)	Effect of fat metabolism by amino acids mixture during exercise on obesity men
Region	Japan

Condition
Condition	No (Subjects whose BMI are 25 to 30)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the lipid metabolism effect by administration of amino acids mixture during exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glycerol level
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Capsules containing 3 g of amino acids mixture, 1 per serving 1 trial
Interventions/Control_2	Capsules containing 3 g of dextrin, 1 per serving 1 trial
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	50 years-old >
Gender	Male
Key inclusion criteria	<1>Subjects giving written informed consent <2>Men 30 to 50 years age 1) Men whose BMI of 25 to 30 and/or visceral fat area less than 200 cm 2. 2) Men who has no regular exercise (30 minutes or more / time more than three times a week)
Key exclusion criteria	<1>Sever systemic diseases <2>Subjects who drink a lot of alcohol <3>Smoker <4>Subjects whose eating habits are extremely irregular. <5>Midnight and irregular shift worker <6>Constant use of oral medication or supplements affecting body fat and/or body <7>Subjects who donated blood within 6 months before starting of administration. <8>Phenylketonuria, and hyperphenylalaninemia <9>Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	12

Research contact person
Name of lead principal investigator	Katsuhisa Sakano
Organization	CPCC Company Limited
Division name	Clinical Research 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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 16 Day
Anticipated trial start date	2015 Year 07 Month 05 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	2015 Year 07 Month 02 Day
Last modified on	2016 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021024