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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022941
Receipt No. R000026364
Scientific Title Effect of intake of supplements containing ornithine on human health.
Date of disclosure of the study information 2017/09/24
Last modified on 2018/07/09

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Basic information
Public title Effect of intake of supplements containing ornithine on human health.
Acronym Ornithine clinical trial
Scientific Title Effect of intake of supplements containing ornithine on human health.
Scientific Title:Acronym Ornithine clinical trial
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effects of supplements containing ornithine on human health.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes GOT
GPT
gamma-GTP
Key secondary outcomes Blood pressure
Serum glucose
LAP
HbA1c
HDL-C
LDL-C
Triglyicerides
Urea nitrogen
Creatinine
Uric acid

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ornithine supplements
2 tablets/day
12 weeks
Interventions/Control_2 Placebo supplements
2 tablets/day
12 weeks
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) Non smokers
(2) Persons who will generally be judged as healthy
(3) Persons who have never suffered from asthma
(4) Persons who have never developed any allegic reaction to medicines, foods, or other substances.
(5) Persons who will give written informed consent by themselves
Key exclusion criteria (1) Persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficay with the effect evaluated in this study
(2) Persons who changed their habitats of supplements whitin 4 weeks.
(3) Persons who work in night shift or in day and night shift
(4) Persons who have been treated their illness or prevention in a clinic at their informed consent
(5) Persons with their medical histories as follows: serious diseases of Sugar metabolism,lipid metabolism, liver function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(6) persons with the medical histories of alcoholism or drug dependence
(7) persons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study preiod
(9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10) persons who will not be judged suitable to the participants by the investigator.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuniyoshi shimizu
Organization Faculty of Agriculture, Kyushu University
Division name Laboratory of Systematic Forest and Forest Products Science
Zip code
Address 6-10-1 Hakozaki, Higashi-ku, Fukuoka
TEL 092-642-3002
Email shimizu@agr.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuniyoshi shimizu
Organization Faculty of Agriculture, Kyushu University
Division name Laboratory of Systematic Forest and Forest Products Science
Zip code
Address 6-10-1 Hakozaki, Higashi-ku, Fukuoka
TEL 092-642-3002
Homepage URL
Email shimizu@agr.kyushu-u.ac.jp

Sponsor
Institute Laboratory of Systematic Forest and Forest Products Science, Faculty of Agriculture, Kyushu University
Institute
Department

Funding Source
Organization Yazuya Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Fuculuty of Humanity-Oriented Science and Eingineering, Kindai University
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
2017 Year 09 Month 24 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 05 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 30 Day
Last follow-up date
2016 Year 09 Month 26 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 11 Month 22 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 29 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026364

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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