UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects fish oil to improve serum lipid level in subjects with borderline hyperlipidemia
Title of the study (Brief title)	The effects fish oil on borderline hyperlipidemia
Region	Japan

Condition
Condition	patients with borderline hyperlipidemia
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to determine the effect of fish oil on improvement of hyperlipidemia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FMD, serum lipid (cholesterol, TG)
Key secondary outcomes	body fat

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	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	fish oil
Interventions/Control_2	olive oil
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	adult male and female 20-65 years old TG; 50-199 mg/dL BT: under 159/99 mmHg LDL cholesterol 120-159 mg/dL BMI under 30cm/m2 subjects who do not take medicine for hyperlipidemia
Key exclusion criteria	1) severe disease including stoke, heart disease, kidney failure 2) after surgery of gastrointestinal tract 3) chronic disease 4) hyperchoresterol with family history 5) abnormal hyperlipidemia 6) severe anemia 7) severe diarrea 8) pregnant 9)allergy with fish 10 already taking medicine or supplement for serum lipid 11) eating fish every day 12) alcohol dependance 13) donation of blood in these 2 weeks 14) participant of other clinical trial in these month 15) other
Target sample size	80

Research contact person
Name of lead principal investigator	Hiroshi Sakaue
Organization	Tokushima University
Division name	Division of Tokushima University
Address	3-18-15 Kumamoto, Tokushima
TEL	088-633-9249
Email	hsakaue@tokushima-u.ac.jp

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

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	Ministry of education Ministry of agriculture
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 08 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 07 Month 25 Day
Anticipated trial start date	2016 Year 08 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	2016 Year 07 Month 04 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=R000026470