UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040281
Receipt number R000045956
Scientific Title Single-blind safety study of increasing dose of amino acid component
Date of disclosure of the study information 2020/05/03
Last modified on 2023/07/20 15:17:11

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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 or person

Institute

International Council on Amino Acid Science

Institute

Department

Personal name



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

Completed

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

2023 Year 07 Month 20 Day



Link to view the page

Value
https://center6.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