Fish Oils and Adipose Inflammation Reduction

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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