Fish Oils and Adipose Inflammation Reduction

Completed · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02010359

Run by

University of Pennsylvania

People needed

29

Starts

2014-06-01

Expected to finish

2017-07-01

Last updated by the study team

2019-02-12

Who can join

Age: 25 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and non-pregnant/lactating women between the ages of 25 and 50.
• Body Mass Index (BMI) ≥30 kg/m2
• Participants who are able to give written informed consent and willing to comply with all study-related procedures.

You may not qualify if…

• Diabetes Mellitus (glucose fasting >126, or random >200, Hemoglobin A1C>6.5 %, or use of any anti-diabetic agent)
• Self-reported fish or shellfish allergy
• Planned usage of any prescription or non-prescription medication (other than contraceptive pills or devices) during the study period.
• Recent (within 6 months) use of fish oil supplements or self- reported dietary intake of >3 servings of fish/month
• Blood pressure >140/90
• Recent (within 6 months) use of statins, niacin, or fenofibrates
• 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.
• 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
• 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
• 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.
• Hemoglobin less than 11.0 g/dL
• Any reported arrhythmia, usage of anti-arrhythmic therapy, or abnormal screening electrocardiogram
• Known bleeding disorder or coagulopathy
• Any major active rheumatologic, pulmonary, hematologic or dermatologic disease or inflammatory condition or minor active infection
• Self-reported history of HIV positive
• Patients who have undergone any organ transplant
• Individuals who currently use tobacco products or have done so in the previous 30 days
• Treatment with aspirin, non steroidal anti-inflammatories, COX-2 inhibitors, steroids or any immunomodulatory therapy 2 weeks prior to the Screening Visit
• 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
• Recent (within 6 months) treatment with coumarin-type anticoagulants
• Positive urine pregnancy test result.
• Self-reported history of injected recreational drug use.
• Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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