Phase 3
N=125
Dose Response Effects of Marine Omega-3 Fatty Acids on Inflammation
Cardiovascular Disease · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT01078909 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment — 1.4; 1.3; 1.4; 1.5 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) (Biological)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Penn State University
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment |
1.4; 1.3; 1.4; 1.5; 1.4; 0.9 | — |
| PRIMARY Mean Concentrations of CRP Following 5 Months of Treatment |
0.6; 0.5; 0.6; 0.6; 0.5 | — |
| SECONDARY Change in Lipid Mediators |
— | — |
Summary
The purpose of this study is to determine the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response to in vivo and ex vivo endotoxin challenge as measured by the production over time of several inflammatory markers.
Eligibility Criteria
Inclusion Criteria
- Healthy men and non-pregnant/lactating women between the ages of 20 and 45
- BMI >19.9 and <30.0
- Able to give written informed consent and willing to comply with all study- related procedures.
Exclusion Criteria
- Previous history of heart disease or diabetes
- Renal Insufficiency
- Chronic anti-inflammatory use
- Systolic blood pressure < 90
- Individuals currently using tobacco products or have done so in the previous 30 days
- Individuals taking Omega-3 fatty acid supplements or their usual intake of fish is greater than 3-4 servings per month.
Data sourced from ClinicalTrials.gov (NCT01078909). 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.