Phase 4
Completed N=29
Fish Oils and Adipose Inflammation Reduction
Source: ClinicalTrials.gov NCT02010359 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Change in Plasma Fractalkine Levels — 0.42; 0.46; 0.48; 0.45 ng/ml
◆ Published Evidence
Established
29citations · ~5 / year
Soy food intake associates with changes in the metabolome and reduced blood pressure in a gut microbiota dependent manner.
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.
Linked Publications
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Soy food intake associates with changes in the metabolome and reduced blood pressure in a gut microbiota dependent manner.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.