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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009902
Receipt No. 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

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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
Institute Kirin Co., Ltd.
Institute
Department

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
URL(English) https://upload.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


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