Effects of Omega-3 Fatty Acids on Markers of Inflammation

Trial ID or NCT#

NCT01129050

Status

not recruiting iconNOT RECRUITING

Purpose

The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.

Official Title

Effects of Plant and Marine Omega-3 (w-3) Fatty Acids on Inflammatory Markers In Insulin Resistant Adults

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. Gender: - Both women and men - Age: > or = 18 years - Ethnicity and race: All ethnic and racial backgrounds welcome - As defined in ATP III of the National Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit: Central obesity as measured by waist circumference: - Men: Greater than 40 inches - Women: Greater than 35 inches - Fasting blood triglycerides greater than or equal to 150 mg/dL - Blood HDL cholesterol: - Men: Less than 40 mg/dL - Women: Less than 50 mg/dL - Blood pressure greater than or equal to 130/85 mmHg - Fasting glucose greater than or equal to 100 mg/dL Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation Ability and willingness to give written informed consent No known active psychiatric illness.
Exclusion Criteria:
  1. Daily intake of dietary supplements containing omega-3 FAs within the past month. - Fasting blood glucose > 140 mg/dL - Significant liver enzyme abnormality - AST or ALT more than 2 times the upper limit of normal and/or - Bilirubin more than 50% the upper limit of normal - Renal disease as measured at baseline: - Serum creatinine > 1.30 mg/dL, or - Calculated creatinine clearance < 71 mL/min - Self reported personal history of: - Clotting disorders - Clinically significant atherosclerosis (e.g., CAD, PAD) - Malignant neoplasm - Ongoing infection - Inflammatory disease (e.g., rheumatoid arthritis) - Subjects currently receiving the following medications (self report): - Anti-Inflammatory drugs - Lipid lowering drugs including statins - Anti-hypertensive drugs - Anti-coagulant drugs - Body Mass Index (BMI) greater than or equal to 40. - Pregnant or Lactating - Inability to communicate effectively with study personnel
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Investigator(s)

Christopher Gardner
Philip S. Tsao, PhD

Contact us to find out if this trial is right for you.

Contact

Antonella Dewell
6507368577

View on ClinicalTrials.gov