Phase 4
N=29
Fish Oils and Adipose Inflammation Reduction
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02010359 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Change in Plasma Fractalkine Levels — 0.42; 0.46; 0.48; 0.45 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lovaza (Drug); Placebo (Drug)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Fractalkine Levels |
0.42; 0.46; 0.48; 0.45 | — |
| SECONDARY Change in Plasma Interleukin 6 (IL-6) |
2.1; 1.8; 2.0; 2.0 | — |
| SECONDARY Change in Plasma Monocyte Chemotactic Protein-1 (MCP-1) |
135; 139; 133; 123 | — |
| SECONDARY Change in Plasma Tumor Necrosis Factor Alpha (TNFalpha) |
0.72; 0.74; 0.76; 0.74 | — |
| SECONDARY Change in the Ratio of Circulating Monocyte Subpopulations |
0.31; 0.35; 0.25; 0.31 | — |
| SECONDARY Change in mRNA Expression of Fractalkine in Adipose |
1.67; 1.06 | — |
| SECONDARY Change in mRNA Levels of MCP-1 in Adipose |
1.2; 1.05 | — |
| SECONDARY Change in mRNA Levels of IL6 in Adipose |
0.91; 1.08 | — |
| SECONDARY Change in mRNA Levels of TNFalpha in Adipose |
1.2; 2.5 | — |
| SECONDARY Change in Ratio of Adipose Tissue Macrophage Subpopulation |
0.52; 0.64; 0.36; 0.42 | — |
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
- 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.
Exclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT02010359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.