N/A Completed N=24 Randomized Quadruple-blind Treatment

Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids

Metabolic Syndrome

Source: ClinicalTrials.gov NCT02670382 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcomePrimary: Interleukin-6 (IL-6) — 0.96; 1.01; 0.99 pg/mL — p=0.33

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.