Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT02670356
Eligibility Criteria:
Inclusion Criteria:
* fasting plasma triglyceride 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
* regular use of anti-inflammatory medications
* Above normal coagulation time or use of anticoagulant medications
* allergy to fish, fish oil, or shellfish
* uncontrolled thyroid dysfunction
* insulin-dependent type 2 diabetes mellitus
* kidney or liver disease
* smoking
* drinking more than 7 alcoholic drinks/week
* use of lipid-lowering medications or medications known to alter lipoprotein metabolism
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT02670356
Study Brief:
Protocol Section:
NCT02670356