Effects of Omega-3 Fatty Acids on the Human Gene Expression
Condition: Hyperlipidemia; Healthy
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Fish oil; Placebo (corn oil)
Intervention description: Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months; corn oil (6 capsules per day)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: Male
Minimum age: 20 Years
Maximum age: 51 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hyperlipidemia; coronary heart disease; gene expression; fish oil; DHA, EPA

Summary:

      The aim of this study is to investigate the effects of short- and long-term intervention with
      EPA and DHA-rich fish oil on gene expression profiles in healthy and hyperlipidemic males.
    

Eligibility criteria:

        Inclusion Criteria:

          -  males, 20-50 years

          -  non-smokers

          -  ethnicity: Caucasians

          -  no medical treatment

          -  healthy subjects:

               -  no documented disease

               -  normal blood lipids (triglyceride < 150 mg/dl; total cholesterol < 200 mg/dl)

          -  humans with increased blood lipids (hyperlipidemia)

               -  documented hypertriglyceridemia or

               -  triglyceride ≥ 150 mg/dl (≥ 1,7 mmol/l) and

               -  total cholesterol > 200 mg/dl (5,2 mmol/l)

          -  written confirmation of the subjects after detailed oral and written explanation about
             the study contents, - requirements and risks

          -  ability and willingness of the participants to attend the investigator's orders
             (compliance of the study conditions, consumption of the study medicaments according to
             the dosage commendation)

        Exclusion Criteria:

          -  Body-Mass-Index (BMI) ≥ 35

          -  smokers

          -  medical treatment (especially corticosteroids, anti-inflammatory drugs, blood lipids
             lowering drugs (e.g. statins, fibrates, bile acid exchanger resin, phytosterols)

          -  taking any supplements with omega-3 fatty acids, phytosterols, polyglucosamines
             (Chitosan) or other lipid binding ingredients

          -  daily consumption of omega-3 fatty acids rich fish (salmon, mackerel, herring)

          -  heavy chronic diseases (tumors, diabetes typ 1, etc.), documented heart disease,
             documented blood clotting disorders, renal failure, liver diseases

          -  documented blood clotting disorders and consumption of coagulation-inhibiting drugs
             (for example Marcumar, ASS)

          -  allergy or intolerance to fish/fish oil or any of the study ingredients of the test
             products

          -  chronic gastro-intestinal diseases (Colitis ulcerosa, Morbus Crohn, pancreatic
             insufficiency)

          -  donation of blood in the last 6 weeks

          -  routine consumption of laxative

          -  common exclusion criteria like

               -  alcohol-, drug- and/or medicament dependence

               -  subjects who are not in agreement with the study conditions

               -  refusal or rather reset of the consent from the subject

               -  active participation in other investigational drug or device trial within the
                  last 30 days