Fish Oil + Red Wine for Oxidative Stress in Healthy Subjects

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Carsten Skarke, MD

Disqualifiers: Cancer, Cardiovascular disease, Blood disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

How does the treatment Fish Oil differ from other treatments for oxidative stress?

Fish Oil is unique because it contains omega-3 fatty acids, which are prone to oxidation, potentially affecting their health benefits. Unlike other treatments, Fish Oil may require additional vitamin E to counteract increased oxidative stress, especially in older individuals. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Fish Oil for reducing oxidative stress?

Research suggests that omega-3 fatty acids, found in fish oil, can increase the body's antioxidant capacity and reduce markers of oxidative stress, which are linked to inflammation and chronic diseases. ^{2 3 5 10 11}

Who Is on the 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

Are You a Good Fit for This Trial?

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

Must be of normal weight with a body mass index (BMI) ≤ 25

I am between 21 and 60 years old.

I am in good health according to my recent medical exams and tests.

Exclusion Criteria

I am not pregnant or nursing a child.

Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject

Complete abstinence from alcohol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Ethanol Administration

Single-arm open oral administration of ethanol in healthy participants

Hours to days

Part 1.1: Fish Oil and Ethanol Administration

Single-arm open oral administration of fish oil capsules and ethanol in healthy participants

Hours to days

Part 2a: Fish Oil or Safflower Oil and Ethanol Administration

Randomized double-blind oral administration of fish oil or safflower oil capsules and ethanol

Hours to days

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

Hours to days

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

Hours to days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fish Oil

Trial Overview The study is examining how high doses of omega-3 & omega-6 fatty acids from fish oil and safflower oil, as well as ethanol from grain alcohol and compounds in red wine affect markers of inflammation and cell stress in blood/urine.

How Is the Trial Designed?

Group I: Fish oil Experimental Treatment 3 Interventions

Omega-3 polyunsaturated fatty acids (n-3 PUFA)

Group II: Safflower Oil Active Control 3 Interventions

Omega-6 polyunsaturated fatty acids (n-6 PUFA)

Who Is Running the Clinical Trial?

Carsten Skarke, MD

Lead Sponsor

Trials

1

Recruited

40+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Dietary intakes of polyunsaturated fatty acids and indices of oxidative stress in human volunteers. [2020]

2. Scotland pubmed.ncbi.nlm.nih.gov

Long-chain omega 3 fatty acids: molecular bases of potential antioxidant actions. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effects of enhanced consumption of fruit and vegetables on plasma antioxidant status and oxidative resistance of LDL in smokers supplemented with fish oil. [2006]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids supplementation and oxidative stress parameters: A systematic review and meta-analysis of clinical trials. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effect of extreme fish consumption on dietary and plasma antioxidant levels and fatty acid composition. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Are the health benefits of fish oils limited by products of oxidation? [2008]

7. England pubmed.ncbi.nlm.nih.gov

A Multi-Year Rancidity Analysis of 72 Marine and Microalgal Oil Omega-3 Supplements. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Vitamin E requirement in relation to dietary fish oil and oxidative stress in elderly. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Vitamin E regulates changes in tissue antioxidants induced by fish oil and acute exercise. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Oxidation of marine omega-3 supplements and human health. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Oxidised fish oil does not influence established markers of oxidative stress in healthy human subjects: a randomised controlled trial. [2022]