Effects of Omega-3 Fatty Acids on Markers of Inflammation

The primary aim 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. Each will be given at a lower dose that could realistically be achieved from
food sources alone, and at a higher dose that could not realistically be achieved from food
alone and would require supplementation. The outcomes being studied are markers of
inflammation. The subjects being studied are those with elevated risk factors for diabetes
and heart disease that meet the criteria for the "metabolic syndrome". These are the people
who are currently not diabetic, and who have not been diagnosed yet with heart disease, who
are at risk of developing these diseases and who would likely benefit the most from the
omega-3 therapy should it prove to be effective.

Inclusion Criteria: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: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