Effects of a Prescription Omega-3 Fatty Acid Concentrate on Induced Inflammation

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess whether the marine omega-3 fatty acids can attenuate inflammatory responses to endotoxin challenge.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Penn State University
• Collaborator: Pronova BioPharma

Criteria

Inclusion Criteria:

1. Men between the ages of 20 and 45.

2. BMI ≥20 and ≤30

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

4. Any race or ethnic background is acceptable

5. Non-smoking

The specific exclusion criteria are:

1. Previous history of vasovagal reactions or unprovoked fainting (I.e. fainting as a result of prolonged standing, exercise)

2. Resting heart rate < 55 bpm

3. History of atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease

4. History of diabetes mellitus (and/or a fasting glucose >126 mg/dL at screening)

5. 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

6. Self-reported history of allergy to fish

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

8. Renal insufficiency as defined by creatinine outside of lab defined normal range at Screening Visit

9. History of liver disease or abnormal LFTs (AST, ALT, Alk. Phos., GGT > 1.5x ULN; bilirubin > 2x ULN) at Screening Visit

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

11. Hemoglobin less than 11.0 g/dL

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

13. Self-reported history of HIV positive

14. Participants who have undergone any organ transplant

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

16. Participants who are unwilling to discontinue use of nutritional supplements, herbs or vitamins unless approved by study staff.

17. 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

18. Elevated blood pressure (BP > 159/99) or use of any anti-hypertensive medications.

19. Latex allergy

20. Unwillingness to refrain from blood donation for 2 months prior to and following endotoxin administration

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

22. Inability to take study capsules

23. History of severe, repeated headaches

24. History of migraine

25. Medical condition that causes severe nausea or vomiting

26. Low resting blood pressure (SBP < 90 mmHg)

27. History of atrial fibrillation/flutter

28. Abnormal coagulation parameters (platelet count, prothrombin time with INR), documented coagulation abnormality, or use of anticoagulant medication

29. High LDL-C (> or = 160 mg/dL)