UMIN-CTR Clinical Trial

Public title

Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial

Acronym

Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial

Scientific Title

Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial

Scientific Title:Acronym

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

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hirona Miura

Organization

Medical Corporation Meiseikai, Higashi Shinjuku Clinic

Division name

Director

Zip code

Address

1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN

TEL

03-6233-8581

Email

higashi-shinjuku@meiseikai-cl.com

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

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

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name

Organization

Maruha Nichiro Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

01

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

01

Month

16

Day

Date of IRB

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

Other related information

Registered date

2017

Year

01

Month

26

Day

Last modified on

2017

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029693