Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers

NAActive, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2028

Conditions
Healthy
Interventions
DRUG

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"

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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"

DIETARY_SUPPLEMENT

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."

DIETARY_SUPPLEMENT

Omega-6 polyunsaturated fatty acid

"Part 2b:~Control omega-6 fatty acid alimentary diet (\<130 mg/day EPA/DHA)"

Trial Locations (1)

19104

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine, Philadelphia

All Listed Sponsors
collaborator

American Heart Association

OTHER

lead

Carsten Skarke, MD

OTHER

NCT00682318 - Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers | Biotech Hunter | Biotech Hunter