40
Participants
Start Date
May 31, 2008
Primary Completion Date
November 30, 2026
Study Completion Date
November 30, 2028
Fish Oil
"Part 1.1: Dose of 9.3 g/day EPA plus 7.5 g/day DHA;~Part 2a (run-in phase): Dose of 1 time 2 capsules per day of Lovaza (total of 1.7 g/d ω-3 PUFA consisting of 930 mg/day EPA and 750 mg/day DHA) for 29±1 days;~Part 2a (study arm): Dose of 3 times 4 capsules per day of Lovaza (total of 10.1 g/d ω-3 PUFA consisting of 5580 mg/day EPA and 4500 mg/day DHA) for 29±1 days"
Safflower Oil
Part 2a: (Study Arm): Omega-6 polyunsaturated fatty acids 3 times 4 capsules per day (total of 10.2 g/d ω-6 PUFA) for 29±1 days
Ethanol
"Part 1 \& Part 1.1:~Dose of 0.9 g/kg body weight 98% alcohol solution~Part 2a:~Doses of 0.4 and 0.9 g/kg body weight 98% alcohol solution and a control placebo drinking solution~Part 2b, Part 3:~Doses of 0.4, 0.6 and 0.9 g/kg body weight 98% alcohol solution"
Omega-3 polyunsaturated fatty acids
"Part 2b:~Alimentary diet delivering ≈ 500 mg/day EPA/DHA,or Alimentary diet delivering ≈ 900-1000 mg/day EPA/DHA, or Alimentary diet delivering ≈ 1500-1800 mg/day EPA/DHA;~Part 3:~Alimentary diet delivering EPA/DHA in a quantity to be determined by Part 2b."
Omega-6 polyunsaturated fatty acid
"Part 2b:~Control omega-6 fatty acid alimentary diet (\<130 mg/day EPA/DHA)"
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine, Philadelphia
American Heart Association
OTHER
Carsten Skarke, MD
OTHER