UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The benefit of fish oil for health promotion in healthy adults.
Title of the study (Brief title)	The benefit of fish oil for health promotion in healthy adults.
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To check the benefit and safety of fish oil
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	serum TG, Cholesterol, NEFA, QOL
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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	fish oil supplement 12/day x 4 weeks
Interventions/Control_2	fish can food 4 days/week X 4weeks, 1can(75g fish) per day
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	healthy adults, male and female, 20-60 years old
Key exclusion criteria	people who eat fish every day people who take medicine people who are diagnosed any disease including metabolic syndrome
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroshi Sakaue
Organization	Tokushima University
Division name	Nutrition and Metabolism
Address	3-18-15 Kumamoto, Tokushima
TEL	088-633-9214
Email	rtsutsumi@tokushima-u.ac.jp

Public contact
Name of contact person	Rie Tsutsumi
Organization	Tokushima University
Division name	Nutrition and Metabolism
Address	3-18-15 Kuramoto, Tokushima
TEL	088-633-9214
Homepage URL
Email	rtsutsumi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	MAFF, MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 15 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 18 Day
Last modified on	2017 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023405