UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of safety and maximum intake of yuzu seed oil capsules.
Title of the study (Brief title)	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	Prof. Shunji Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical nursing
Address	Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL	088-866-5811
Email	mizoshun@kochi-u.ac.jp

Public contact
Name of contact person	Shunji Mizobuchi
Organization	Kochi Medical School, Kochi University
Division name	Clinical nursing
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020333