Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia (FFAME)

This is an interventional basic science trial for Cardiovascular Disease focused on measuring healthy volunteer Read More

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