Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia

Inclusion Criteria:

- Men and non-pregnant/lactating women between the ages of 18 and 45.

- Body Mass Index (BMI) ≥18 and ≤30

- Participants who are able to give written informed consent and willing to comply with
all study-related procedures.

Exclusion Criteria:

- Known clinically manifest atherosclerotic cardiovascular disease, including coronary
disease, cerebrovascular disease, or peripheral vascular disease

- History of diabetes mellitus

- Fasting glucose >126mg/dL at screening

- History of a non-skin malignancy within the previous 5 years

- Renal insufficiency as defined by creatinine outside of lab defined normal range or
eGFR <60 ml/Kg/min at Screening Visit

- History of liver disease or abnormal Liver Function Tests (LFTs) (aspartate
aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase,
gamma-glutamyl transpeptidase (GGT) > 1.5x upper limit of normal (ULN); bilirubin >
2x ULN) at Screening Visit

- Men who are unwilling to limit alcohol consumption to < 14 alcoholic drinks per week
or < 4 alcoholic drinks per occasion (American Medical Association/National Institute
on Alcohol Abuse and Alcoholism (AMA / NIAAA) criteria for "at risk" usage levels)
while participating in the study

- Women who are unwilling to limit alcohol consumption to < 7 alcoholic drinks per week
or < 3 alcoholic drinks per occasion (AMA / NIAAA criteria for "at risk" usage
levels) while participating in the study

- Total white blood cell count less than or equal to 3.0 THO/uL

- Hemoglobin less than 11.0 g/dL

- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory
condition or minor active infection

- Self-reported history of HIV positive

- First degree family history of premature cardiovascular disease event (father or
brother if diagnosed at before 55 years of age; mother or sister if diagnosed before
65 years of age)

- Patients who have undergone any organ transplant

- Individuals who currently use tobacco products or have done so in the previous 30
days

- Treatment with aspirin, Nonsteroidal Anti-inflammatory Drugs (NSAIDs),
cyclooxygenase-2 (COX-2) inhibitors, steroids or any immunomodulatory therapy 2 weeks
prior to the Screening Visit

- Treatment with statins, fibrates or niacin 4 weeks prior to the Screening Visit.

- Current daily use of Vitamin C > 1000 mg, Beta carotene > 1000 IU, vitamin A > 5000
IU, vitamin E > 400 IU, and selenium > 200 mcg

- Participants who are unwilling to eliminate omega-3 fatty acid (eicosapentaenoic acid
(EPA) + docosahexaenoic acid (DHA)) supplements and/or fortified food, or have their
usual intake of high omega-3 fish (tuna and other non-fried fish) be > 3 to 4
servings per month as assessed by a simple screening questionnaire

- Positive urine pregnancy test result.

- Participation in another clinical trial within the previous 6 weeks prior to the
Screening Visit.

- Poorly controlled blood pressure (BP > 160/110) or on any anti-hypertensive
medications.

- A diagnosis of metabolic syndrome using updated 2004 National Cholesterol Education
Program Adult Treatment Panel III (NCEP ATPIII) criteria.

- Any medical condition or abnormal laboratory value that is judged clinically
significant by an investigator