N/A
N=24
Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02670382 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Interleukin-6 (IL-6) — 0.96; 1.01; 0.99 pg/mL — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EPA (Dietary_supplement); DHA (Dietary_supplement); sunflower oil (Dietary_supplement)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interleukin-6 (IL-6) |
0.96; 1.01; 0.99 | 0.33 |
| PRIMARY Tumor Necrosis Factor Alpha (TNF-alpha) |
2.38; 2.48; 2.47 | 0.34 |
| PRIMARY Low Density Lipoprotein Cholesterol (LDL-C) |
130; 136; 140 | 0.10 |
Summary
The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.
Eligibility Criteria
Inclusion criteria
- fasting plasma TG levels between 150 and 500 mg/dL
- C-reactive protein (CRP) levels ≥2 µg/mL
- at least one of the following criteria for the definition of metabolic syndrome:
- abdominal obesity (waist circumference >40 inches in men and >35 inches in women),
- hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and
- fasting glucose ≥110 mg/dL.
Exclusion criteria
- high-fish diets (>2 fish meals/week)
- taking fish oil supplements or supplements containing EPA or DHA
- allergy to sardines
- allergy to sunflower oil
- regular use of anti-inflammatory medications (NSAID, COX inhibitors, corticosteroids)
- anticoagulant therapy
- alcohol consumption >7 drinks/week
- uncontrolled thyroid dysfunction
- insulin-dependent type 2 diabetes mellitus
- kidney or liver disease
- smoking
- alterations in coagulation
- use of lipid altering medications
Data sourced from ClinicalTrials.gov (NCT02670382). 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.