Fish Oil + Red Wine for Oxidative Stress in Healthy Subjects
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it does require a 'washout period' of at least five weeks without vitamin supplements before enrolling. It's best to discuss your specific medications with the trial organizers.
What data supports the effectiveness of the treatment Fish Oil for reducing oxidative stress?
Is fish oil safe for human consumption?
Fish oil is generally considered safe for human consumption, but some fish oils may contain oxidized products that could reduce their health benefits. Studies suggest that omega-3 fatty acids in fish oil can improve antioxidant levels in the body, but the freshness and oxidation levels of the supplements can vary, potentially affecting safety.12467
How does the treatment Fish Oil differ from other treatments for oxidative stress?
What is the purpose of this trial?
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.
Research Team
Carsten Skarke, M.D.
Principal Investigator
Institute for Translational Medicine & Therapeutics, SOM
Garret FitzGerald, MD
Principal Investigator
Institute for Translational Medicine & Therapeutics, School of Medicine
Eligibility Criteria
Healthy adults aged 21-60, non-smokers with a BMI ≤ 25 (or at the PI's discretion), not pregnant or nursing, using contraception if applicable. Must abstain from alcohol and vitamin supplements for specific periods before the trial and agree to regular pregnancy tests if female.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Ethanol Administration
Single-arm open oral administration of ethanol in healthy participants
Part 1.1: Fish Oil and Ethanol Administration
Single-arm open oral administration of fish oil capsules and ethanol in healthy participants
Part 2a: Fish Oil or Safflower Oil and Ethanol Administration
Randomized double-blind oral administration of fish oil or safflower oil capsules and ethanol
Part 2b: Fish Foods or Control Diet and Ethanol Administration
Randomized double-blind oral administration of fish foods or control diet and open oral administration of ethanol
Part 3: Fish Foods or Control Diet and Red Wine Administration
Randomized double-blind oral administration of fish foods or control diet and red wine beverages
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fish Oil
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carsten Skarke, MD
Lead Sponsor
American Heart Association
Collaborator