UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial
Title of the study (Brief title)	Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial
Region	Japan

Condition
Condition	N/A (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This trial aims effects and safety of intake time of sausage added fish oil (DHA & EPA) on blood fatty acid, blood triglycerides, and hepatic gene expression involved in lipid metabolism.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Blood fatty acid fracitionation (Week 0, Week 4, Week 8)
Key secondary outcomes	*Secondary outcomes [1]Gene expression (hepatic gene involved in lipid metabolism, clock gene, housekeeping gene) (Week 0, Week 4, Week 8) [2]Triglyceride (Screening, Week 0, Week 4, Week 8) [3]Insulin (Week 0, Week 4, Week 8) [4]Glycoalbumin (Week 0, Week 4, Week 8) [5]Total cholesterol (Week 0, Week 4, Week 8) [6]LDL cholesterol (Week 0, Week 4, Week 8) [7]HDL cholesterol (Week 0, Week 4, Week 8) *Safety [1]Blood pressure (Screening, Week 0, Week 4, Week 8) [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8) [3]Blood test (adiponectin) (Screening, Week 0, Week 4, Week 8) [4]Blood biochemical test (Screening, Week 0, Week 4, Week 8) [5]Urine analysis (Screening, Week 0, Week 4, Week 8) [6]Doctor's questions (Screening, Week 0, Week 4, Week 8) [7]Subject's diary (From the first day of ingestion of a test material to the last day of the test) *Other indexes [1]Blood fatty acid fracitionation (DHA, EPA, DHLA, AA) (Screening) [2]Blood-borne infection (Screening)

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 Device,equipment
Interventions/Control_1	Oral intake of sausage added fish oil (DHA & EPA) at breakfast or dinner (1 piece per a day [50g] ; 8 weeks)
Interventions/Control_2	Oral intake of sausage not added fish oil (DHA & EPA) at breakfast or dinner (1 piece per a day [50g] ; 8 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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	[1]Males and Females aged 20-60 years. [2]Individuals who are healthy and don't receive treatment. [3]Individuals whose written informed consent has been obtained. [4]Individuals who can have an examination in a designated day. [5]Individuals who can stop intaking blue-backed fishes (tuna, saury, horse mackerel, mackerel, yellowtail, seriola; including processed foods like canned food) during the test period. [6]Individuals judged appropriate for the trial by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals who use a drug for treatment of disease. [3]Individuals who are patient or have a history of hyperlipidemia, high blood pressure, diabetes, psychiatric disease, and sleep disorder. [4]Individuals who have a custom to intake blue-backed fishes (tuna, saury, horse mackerel, mackerel, yellowtail, seriola; including processed foods like canned food) over 3 days per a week. [5]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [6]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. [7]Individuals who have a history of digestive system disease. [8]Individuals whose BMI is over 30. [9]Individuals whose blood neutral lipid is over 200mg/dL. [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [11]Individuals who are a smoker. [12]Individuals with serious anemia. [13]Individuals who are sensitive to a test product or other foods, and medical products. [14]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 month or will ingest those foods during the test period. [15]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [16]Individuals who are or are possibly, or are lactating. [17]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [18]Individuals who participated in other clinical studies in the past 3 months. [19]Individuals who are or whose family is a employee of a health food, functional food, or cosmetic company. [20]Individuals judged inappropriate for the trial by the principal.
Target sample size	20

Research contact person
Name of lead principal investigator	Hirona Miura
Organization	Medical Corporation Meiseikai, Higashi Shinjuku Clinic
Division name	Director
Address	1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN
TEL	03-6233-8581
Email	higashi-shinjuku@meiseikai-cl.com

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization	Maruha Nichiro Corporation
Organization
Division
Category of Funding Organization	Profit 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	2017 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 16 Day
Anticipated trial start date	2017 Year 01 Month 27 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	2017 Year 01 Month 26 Day
Last modified on	2017 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029693