UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000024506
Receipt number	R000028205
Scientific Title	A clinical study for evaluating the safety of excessive intake of amino acid mixture in a double-blind, placebo-controlled study.
Date of disclosure of the study information	2016/10/23
Last modified on	2017/04/21 09:16:32

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Basic information

Public title

A clinical study for evaluating the safety of excessive intake of amino acid mixture in a double-blind, placebo-controlled study.

Acronym

A clinical study for evaluating the safety of excessive intake of amino acid mixture.

Scientific Title

A clinical study for evaluating the safety of excessive intake of amino acid mixture in a double-blind, placebo-controlled study.

Scientific Title:Acronym

A clinical study for evaluating the safety of excessive intake of amino acid mixture.

Region

Japan

Condition

Classification by specialty

Medicine in general Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

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

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

Intervention

No. of arms

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

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yasuo Kobuna

Organization

Kobuna Orthopedics Clinic

Division name

Director

Zip code

Address

311-2 Gokan-machi, Maebashi-shi, Gumma, Japan

TEL

027-261-7600

Email

info@kobunaseikei.jp

Public contact

Name of contact person

1st name

Middle name

Last name Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

Address

1-9-7 Shibaura, Minato-ku, Tokyo, Japan

TEL

03-3452-7733

Homepage URL

Email

yoshikawa@kso.co.jp

Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name

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)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 23 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 10 Month 21 Day

Date of IRB

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

Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028205

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name