Effect of Intake Time of Fish Oil (DHA & EPA) on Serum Lipids in Healthy Adults: A Randomized, Placebo-Controlled, Parallel Group Trial
- Conditions
- /A (healthy adults)
- Registration Number
- JPRN-UMIN000025849
- Lead Sponsor
- TES Holdings Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
[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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [1]Blood fatty acid fracitionation (Week 0, Week 4, Week 8)
- Secondary Outcome Measures
Name Time Method *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)