drugset / Trial / NCT00682318

Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers

NCT00682318

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2008-05
Primary completion
2028-11
Completion
2029-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Fish oil Other / unclassified 7.5 g Oral
Subject Fish oil Other / unclassified 9.3 g Oral
Subject Fish oil Other / unclassified 10.1 g Oral

Indications

No indication recorded.