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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how fish oil, containing omega-3 fatty acids, impacts inflammation and cell stress, potentially affecting heart health. Researchers compare different combinations of fish oil, safflower oil (with omega-6 fatty acids), and red wine to determine which best reduces these stress markers. Healthy, non-smoking adults with a normal weight who don’t take vitamin supplements may find this trial a great fit. The goal is to better understand these substances' effects to potentially reduce heart disease risk. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking heart health research.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fish oil, which contains omega-3 fatty acids, is generally safe for most people. Studies have found that omega-3 fatty acids from fish oil are usually well-tolerated. Some individuals might experience minor side effects, such as a fishy taste or mild stomach issues, but serious side effects are rare.

Health organizations commonly recommend omega-3 fatty acids, indicating their safety. For instance, they are often suggested for heart health, reflecting confidence in their safety when used as directed.

In summary, fish oil is considered safe, and many people use it without major issues. Consulting a healthcare provider before starting any new supplement, especially in high doses, is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of fish oil and red wine because it brings a fresh approach to managing oxidative stress. Unlike standard treatments that focus on antioxidants like vitamins C and E, fish oil provides omega-3 polyunsaturated fatty acids, which have unique anti-inflammatory properties. Additionally, red wine contributes resveratrol, a compound known for its potential to improve heart health. Together, these natural ingredients might offer a more holistic and potentially synergistic way to combat oxidative stress, potentially offering benefits beyond those of traditional antioxidant supplements.

What evidence suggests that this trial's treatments could be effective for oxidative stress?

Research has shown that fish oil, rich in omega-3 fatty acids, might help reduce cell damage and swelling in the body. One study found that omega-3s from fish oil decreased stress-induced damage in blood vessel cells. Another study discovered that dietary omega-3s could lower cell damage and swelling, which are linked to various health problems. Omega-3s may help control body processes and stress levels. Although the overall evidence is mixed, these findings suggest fish oil may help the body fight inflammation and cell damage. Participants in this trial will receive either fish oil or safflower oil to assess their effects on oxidative stress. ^{6 7 8 9 10}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10451159/

n-3 Polyunsaturated Fatty Acid Supplementation Affects ... n-3 polyunsaturated fatty acid supplementation affects oxidative stress marker levels in patients with type II intestinal failure: a randomized double blind ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0187934

Fish oil omega-3 polyunsaturated fatty acids attenuate ... Fish oil omega-3 polyunsaturated fatty acids attenuate oxidative stress-induced DNA damage in vascular endothelial cells. Chiemi Sakai, Mari Ishida, Hideo ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1043661819311910

Omega-3 fatty acids supplementation and oxidative stress ... Previous evidence have demonstrate that omega-3 FAs in diet may decrease OS and inflammation [7]. Omega-3 FAs are polyunsaturated fatty acids which mostly exist ...

4. apm.amegroups.org apm.amegroups.org/article/view/77612/html

Efficacy of omega-3 polyunsaturated fatty acids on hormones ... In recent years, studies have shown that dietary fat is currently considered as a biological regulator affecting metabolism, and ω- Polyunsaturated fatty acids ...

5. mdpi.com mdpi.com/2072-6643/13/2/662

Narrative Review of n-3 Polyunsaturated Fatty Acid ... Bonilla et al. [33] studied fat-1 mice with elevated levels of endogenous n-3 polyunsaturated fatty acids and reported increased susceptibility to Mycobacterium ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8533147/

Omega−3 Polyunsaturated Fatty Acids (PUFAs) The omega−3 (n−3) polyunsaturated fatty acids (PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) acid are well known to protect against numerous ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523069605

Safety considerations of polyunsaturated fatty acids It has also been proposed that the association between fat intake and cancer could be attributed to the trans fatty acid component (67), but this hypothesis is ...

8. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000482

Omega-3 Polyunsaturated Fatty Acid (Fish Oil) ... Absorption of both ethyl esters and free fatty acids is enhanced by the presence of dietary fat. omega-3 PUFA Supplementation and Clinical CVD.

9. sciopen.com sciopen.com/article/10.31665/JFB.2019.7192

Are there serious adverse effects of omega-3 ... Bailey's industrial oil and fat products (7th Ed. ). Wiley. Crossref. Lange, K.W. (2019c). Omega-3 fatty acids ...

10. fjps.springeropen.com fjps.springeropen.com/articles/10.1186/s43094-024-00667-5

Omega-3 fatty acids: a comprehensive scientific review of their ... The primary sources of marine n − 3 fatty acid supplements are oily fish, such as anchovies, sardines and mackerel. Recently, they have drawn ...