UMIN-CTR Clinical Trial

Basic information
Public title	Single-blind safety study of increasing dose of amino acid component
Acronym	Single-blind safety study of increasing dose of amino acid component
Scientific Title	Single-blind safety study of increasing dose of amino acid component
Scientific Title:Acronym	Single-blind safety study of increasing dose of amino acid component
Region	Japan

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

Objectives
Narrative objectives1	Confirmation of safe intake of test food by ingesting test food (low to 4 doses) for 30 weeks in 30 healthy adult males and evaluating the occurrence of adverse events after ingestion of test food
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in laboratory test values
Key secondary outcomes	Ratio of incidence on adverse event

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food A, Test food B, Test food C, Test food D Treatment1, Washout, Treatment2, Washout, Treatment3, Washout, Treatment4
Interventions/Control_2
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	60 years-old >
Gender	Male
Key inclusion criteria	1. Healthy men aged between 20 and 60 at the time of consent 2. Subjects who gave written consent after fully understanding the purpose and content of this study
Key exclusion criteria	1.Subjects who have or are likely to ingest the drug continuously during the intake period of the test food 2.Subjects taking or scheduled to take supplements containing amino acids as the main component from the time of participation in the study to the end of the study food intake period 3.Subjects who are participating in other human trials as test subjects, or within 4 weeks after the end of the trials in which they participated, or subjects scheduled to participate during the main study period 4.Subjects who meet any of the following 1) Subjects with heart, liver, or kidney disease (including cases of complications of other diseases) 2) Subjects with respiratory disease 3) Subjects with a history of cardiovascular disease 4) Subjects with diabetes 5) Subjects with intestinal disorders 6) Subjects who are undergoing treatment or have a history of treating serious diseases such as cancer and tuberculosis Subjects with respiratory disease 5. Subjects with pharmaceutical or food allergies 6. In addition to the above, those who are judged by the investigator to be unsuitable for the test
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Smriga Middle name Last name Miro
Organization	International Council on Amino Acid Science
Division name	Secretariat Office
Zip code	104-0032
Address	3F, 3-11-8 Hatchobori Chuo-ku, Tokyo 104-0032, JAPAN
TEL	03-3537-7021
Email	secretariat01@e-icaas.org

Public contact
Name of contact person	1st name Makoto Middle name Last name Terashima
Organization	Oneness Support Co., Ltd.
Division name	Clinical Trial Division
Zip code	530-0044
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	International Council on Amino Acid Science
Institute
Department

Funding Source
Organization	International Council on Amino Acid Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Miura Clinic, Medical Corporation Kanonkai IRB
Address	Higashitenma building 9F, 1-7-17, Higashitenma,Kita-ku, Osaka, Japan
Tel	06-6135-5200
Email	mterashima@miura-cl.jp

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	医療法人花音会みうらクリニック（大阪市）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 03 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	Preinitiation
Date of protocol fixation	2020 Year 02 Month 19 Day
Date of IRB	2020 Year 02 Month 20 Day
Anticipated trial start date	2020 Year 05 Month 04 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 01 Day
Last modified on	2020 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045956

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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