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:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT00350194
Eligibility Criteria:
Inclusion Criteria:
* Adults with Metabolic Syndrome (meets 3 of the following 5)
* Abdominal obesity, waist circumference in men greater than 40 in. \& in women greater than 35 in.
* Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)
* Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women
* Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure
* Fasting plasma glucose greater than 100 mg/dL
Exclusion Criteria:
* Diabetes
* Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)
* Angina or other chest pain that may indicate CHD
* Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
* Known abnormal LFTS greater than 2X ULN
* Smoker, illicit drug use, or excessive alcohol use
* Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months
* Pregnancy or planning pregnancy during the study period
* Sensitivity or allergy to fish
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00350194
Study Brief:
Protocol Section:
NCT00350194