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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2017
INTERVENTION: Oral intake of sausage added fish oil (DHA & EPA) at breakfast or dinner (1 piece per a day [50g] ; 8 weeks) Oral intake of sausage not added fish oil (DHA & EPA) at breakfast or dinner (1 piece per a day [50g] ; 8 weeks) CONDITION: N/A (healthy adults) PRIMARY OUTCOME: [1]Blood fatty acid fracitionation (Week 0, Week 4, Week 8) SECONDARY OUTCOME: *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) 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.
Epistemonikos ID: 4d67e3bcdc3e773dd5ed721a51e873bb612eacbf
First added on: Aug 23, 2024