Fish Oils and Adipose Inflammation Reduction
Condition: Obesity
Intervention: Lovaza; Placebo
Intervention description: Lovaza 4 grams per day; Placebo pill
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 25 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is a clinical trial designed to assess whether fish oil treatments are effective
      in the prevention of obesity-related fat tissue (adipose) inflammation. Specifically it
      addresses the hypothesis that fish oils treatments will reduce signaling by chemokine
      pathways (fractalkine and MCP-1) important in adipose tissue for the recruitment and
      activation of certain white blood cells (macrophages). The study is a double-blind
      placebo-controlled trial of the fish oil Lovaza from GlaxoSmithKline (omega-3-acid ethyl
      esters; a combination of ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid
      (DHA)) in obese non-diabetic adults, to determine if Lovaza decreases markers of inflammation
      and macrophage activation in adipose and blood and understand the mechanism by which fish
      oils affect inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and non-pregnant/lactating women between the ages of 25 and 50.

          2. Body Mass Index (BMI) ≥30 kg/m2

          3. Participants who are able to give written informed consent and willing to comply with
             all study-related procedures.

        Exclusion Criteria:

          1. Diabetes Mellitus (glucose fasting >126, or random >200, Hemoglobin A1C>6.5 %, or use
             of any anti-diabetic agent)

          2. Self-reported fish or shellfish allergy

          3. Planned usage of any prescription or non-prescription medication (other than
             contraceptive pills or devices) during the study period.

          4. Recent (within 6 months) use of fish oil supplements or self- reported dietary intake
             of >3 servings of fish/month

          5. Blood pressure >140/90

          6. Recent (within 6 months) use of statins, niacin, or fenofibrates

          7. Current or planned pregnancy/lactation. Pre-menopausal women unwilling to prevent
             pregnancy by use of the following approved contraceptive strategies: diaphragm,
             cervical cap, condom with spermicide, surgical sterility, birth control pills,
             Depo-Provera injection, Intra-uterine device, progestin implant, or abstinence.

          8. History of liver disease or abnormal liver function tests (aspartate aminotransferase,
             Alanine transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase > 1.5x Upper
             Limit normal; bilirubin > 2x upper limit normal) at Screening Visit

          9. Men who are unwilling to limit alcohol consumption to < 14 alcoholic drinks per week
             or < 4 alcoholic drinks per occasion while participating in the study

         10. Women who are unwilling to limit alcohol consumption to < 7 alcoholic drinks per week
             or < 3 alcoholic drinks per occasion while participating in the study.

         11. Hemoglobin less than 11.0 g/dL

         12. Any reported arrhythmia, usage of anti-arrhythmic therapy, or abnormal screening
             electrocardiogram

         13. Known bleeding disorder or coagulopathy

         14. Any major active rheumatologic, pulmonary, hematologic or dermatologic disease or
             inflammatory condition or minor active infection

         15. Self-reported history of HIV positive

         16. Patients who have undergone any organ transplant

         17. Individuals who currently use tobacco products or have done so in the previous 30 days

         18. Treatment with aspirin, non steroidal anti-inflammatories, COX-2 inhibitors, steroids
             or any immunomodulatory therapy 2 weeks prior to the Screening Visit

         19. Participants who are unwilling to eliminate omega-3 fatty acid (EPA + DHA) supplements
             and/or fortified food, or have their usual intake of high omega-3 fish (tuna and other
             non-fried fish) be > 3 to 4 servings per month as assessed by a simple screening
             questionnaire

         20. Recent (within 6 months) treatment with coumarin-type anticoagulants

         21. Positive urine pregnancy test result.

         22. Self-reported history of injected recreational drug use.

         23. Any medical condition or abnormal laboratory value that is judged clinically
             significant by an investigator