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ACTIVE NOT RECRUITING
NCT00682318
NA

Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers

Sponsor: Carsten Skarke, MD

View on ClinicalTrials.gov

Summary

The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.

Official title: Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers: a Randomized Double-blinded Trial on the Modulation of the Eicosanoid and Isoprostane Pathways in Healthy Subjects by Omega-3 Polyunsaturated Fatty Acids and Red Wine.

Key Details

Gender

All

Age Range

21 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2008-05

Completion Date

2029-11

Last Updated

2026-02-24

Healthy Volunteers

Yes

Conditions

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)

Locations (1)

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

Philadelphia, Pennsylvania, United States