UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the safety of excessive intake of amino acid mixture in a double-blind, placebo-controlled study.
Title of the study (Brief title)	A clinical study for evaluating the safety of excessive intake of amino acid mixture.
Region	Japan

Condition
Condition	No
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive intake of amino acid mixture for 4 weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Biochemistry test Urinalysis Blood pressure/pulse Weight/body mass index Medical interview Adverse event
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	placebo intake
Interventions/Control_2	test food intake
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Adults 20 to 65 years age 2) Subjects whose BMI of 18.5 to 30 kg/m^2 3) Subjects giving written informed consent
Key exclusion criteria	1) Subjects who regularly use medication affecting obesity, hyperlipidemia, lipid metabolism. 2) Subjects who cantract serious diseases (e.g., liver disease, heart disease, respiratory disease, endocrine disease, metabolic disorder, food allergic disease.) 3) Subjects who can't stop using supplements and/or functional foods affecting obesity, hyperlipidemia, lipid metabolism. 4) Subjects whoare under treatment for or have a history of drug addication and/or alcoholism. 5) Subjects who can't stop drinking from 2 days before each inspection date. 6) Subjects who have medical history of deseases or surgeries which affect digestion and absorption. 7) Phenylketonuria, and hyperphenylalaninemia 8) Subjects who have been diagnosed with familial hyperlipidemia 9) Subjects who are pregnant or nursing, or who wish to become pregnant during the study. 10) Subjects whose eating habits are extremely irregulae (ex. midnight and irregulae shift worker) 11) Subjects who are planning to participate in other clinical studies. 12) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	30

Research contact person
Name of lead principal investigator	Yasuo Kobuna
Organization	Kobuna Orthopedics Clinic
Division name	Director
Address	311-2 Gokan-machi, Maebashi-shi, Gumma, Japan
TEL	027-261-7600
Email	info@kobunaseikei.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 21 Day
Anticipated trial start date	2016 Year 10 Month 24 Day
Last follow-up date	2017 Year 01 Month 17 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 03 Month 01 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 10 Month 20 Day
Last modified on	2017 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028205