PRONOVAEffects of a Prescription Omega-3 Fatty Acid Concentrate in a Placebo-controlled Trial of Human Endotoxemia

Date de début de l'étude : 1 mai 2014

Inclusion Criteria: Men between the ages of 20 and 45. BMI ≥20 and ≤30 Participants who are able to give written informed consent and willing to comply with all study-related procedures. Any race or ethnic background is acceptable Non-smoking The specific exclusion criteria are: Previous history of vasovagal reactions or unprovoked fainting (I.e. fainting as a result of prolonged standing, exercise) Resting heart rate < 55 bpm History of atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease History of diabetes mellitus (and/or a fasting glucose >126 mg/dL at screening) Chronic anti-inflammatory medication use or treatment with aspirin, NSAIDs, COX-2 inhibitors; steroids or any immunomodulatory therapy 2 weeks prior to the screening visit Self-reported history of allergy to fish History of a non-skin malignancy within the previous 5 years Renal insufficiency as defined by creatinine outside of lab defined normal range at Screening Visit History of liver disease or abnormal LFTs (AST, ALT, Alk. Phos., GGT > 1.5x ULN; bilirubin > 2x ULN) at Screening Visit 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 Participants who have undergone any organ transplant Individuals who currently use tobacco products or have done so in the previous 30 days. Participants who are unwilling to discontinue use of nutritional supplements, herbs or vitamins unless approved by study staff. Participants who are unwilling to eliminate omega-3 fatty acid (EPA + DHA) supplements and/or fortified food, or have a usual intake of high omega-3 fish (tuna and other non-fried fish) > 2 servings per week Elevated blood pressure (BP > 159/99) or use of any anti-hypertensive medications. Latex allergy Unwillingness to refrain from blood donation for 2 months prior to and following endotoxin administration Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator Inability to take study capsules History of severe, repeated headaches History of migraine Medical condition that causes severe nausea or vomiting Low resting blood pressure (SBP < 90 mmHg) History of atrial fibrillation/flutter Abnormal coagulation parameters (platelet count, prothrombin time with INR), documented coagulation abnormality, or use of anticoagulant medication High LDL-C (> or = 160 mg/dL)