UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009902
Receipt number R000011603
Scientific Title Effect of ornithine on blood and transdermal secretion of ammonia and on muscle fatigue
Date of disclosure of the study information 2013/01/30
Last modified on 2013/01/30 11:24:26

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Basic information

Public title

Effect of ornithine on blood and transdermal secretion of ammonia and on muscle fatigue

Acronym

Effect of ornithine on ammonia reduction

Scientific Title

Effect of ornithine on blood and transdermal secretion of ammonia and on muscle fatigue

Scientific Title:Acronym

Effect of ornithine on ammonia reduction

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of ornithine intake on blood and transdermal secretion of ammonia before and after incremental exercise in healthy adult.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood ammonia, transdermal secretion of ammonia

Key secondary outcomes

Blood glucose, lactate, urea nitrogen, lactate dehydrogenase, creatine phosphokinase


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of ornithine 2.4 g followed by single ingestion of placebo

Interventions/Control_2

Single ingestion of placebo followed by single ingestion of ornithine 2.4 g

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

40 years-old >

Gender

Male

Key inclusion criteria

1)Male subjects between 20 and 40 year of age at the time of consent
2)Subjects with regular exercise about once a week, less than six times a month
3)Non-smoker

Key exclusion criteria

1)Subjects who regularly take ornithine supplements.
2)Subjects who aware perspire freely or modestly after moderate exercise.
3)Subjects who have illness under medical treatment.
4)Subjects who may possibly develop
allergic reactions associated with the test products
5) Subjects who have critical disease history such as diabetes, hepatic disorder, kidney disorder, cardiac disorder.
6)Subjects who are considered inappropriate by the result of selection visit
7)Subjects who participate in another clinical study at the beginning of this study
8)Subjects who are judged not appropriate for this study by study physician

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Miura

Organization

Kirin Co., Ltd.

Division name

Research laboratories for health science & food technologies

Zip code


Address

1-13-5, Fukuura Kanazawa Yokohama Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Kokubo

Organization

Kirin Co., Ltd.

Division name

Research laboratories for health science & food technologies

Zip code


Address

1-13-5, Fukuura Kanazawa Yokohama Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Kirin Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

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

2013 Year 01 Month 30 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

2010 Year 09 Month 07 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 17 Day

Last follow-up date

2010 Year 10 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 30 Day

Last modified on

2013 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011603


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name