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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017543
Receipt No. R000020333
Scientific Title Assessment of safety and maximum intake of yuzu seed oil capsules.
Date of disclosure of the study information 2015/05/13
Last modified on 2016/12/03

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Basic information
Public title Assessment of safety and maximum intake of yuzu seed oil capsules.
Acronym Safety of yuzu seed oil capsules.
Scientific Title Assessment of safety and maximum intake of yuzu seed oil capsules.
Scientific Title:Acronym Safety of yuzu seed oil capsules.
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to evaluate the safety of daily intake of yuzu seed oil capsules and to determine the maximum amount of yuzu seed oil that can be taken safely.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hematologic test
Blood biochemistry test
Doctor's questions
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral ingestion of four yuzu seed oil capsules daily for 12 weeks.
Interventions/Control_2 Oral ingestion of six yuzu seed oil capsules daily for 12 weeks.
Interventions/Control_3 Oral ingestion of eight yuzu seed oil capsules daily for 12 weeks.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.That whose age at the time of informed consent is aged 20 and over.
2.Those who can understand the purpose and the contents of this study, and can agree with participation to this study by letter.
Key exclusion criteria having a disease
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical nursing
Zip code
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-866-5811
Email mizoshun@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunji Mizobuchi
Organization Kochi Medical School, Kochi University
Division name Clinical nursing
Zip code
Address Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL 088-880-2564
Homepage URL
Email mizoshun@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

Funding Source
Organization Umajimura agricultural cooperative
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 高知大学医学部

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 13 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
2015 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 13 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 05 Month 20 Day
Date analysis concluded
2016 Year 05 Month 20 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 13 Day
Last modified on
2016 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020333

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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