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Omega-3 polyunsaturated fatty acid

Fish Oil + Red Wine for Oxidative Stress in Healthy Subjects

N/A
Waitlist Available
Led By Carsten Skarke, M.D.
Research Sponsored by Carsten Skarke, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 21 - 60
Must be non-smoking volunteers (both male and non-pregnant females) due to a significant influence of smoking and overweight on the outcome measures of lipid peroxidation
Must not have
Female subjects who are pregnant or nursing a child
Subjects with nutritional inefficiencies in Fe, Zn, Cu, Mg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hours to months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of fish oil on blood and urinary markers of inflammation and cell stress.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include digestive issues due to fish oil consumption, allergic reactions in those sensitive to fish products, and possible intoxication symptoms from ethanol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 60 years old.
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I am a non-smoker and not pregnant.
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I am a man who is sterile or will use condoms during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or nursing a child.
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I have low levels of iron, zinc, copper, or magnesium.
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I have no history of significant heart, kidney, liver, lung, hormone, blood, or nerve disorders.
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I have a digestive condition that affects how my body absorbs fat.
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I have had cancer before, including skin cancer.
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I have a condition related to blood clotting or bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hours to months
This trial's timeline: 3 weeks for screening, Varies for treatment, and hours to months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Urinary isoprostane concentrations
Secondary study objectives
Blood alcohol concentrations
Blood fatty acid composition
Compositional Changes in the Intestinal Microbiome
+2 more
Other study objectives
Metabolomics, Lipidomics, Transcriptomics

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fish oilExperimental Treatment3 Interventions
Omega-3 polyunsaturated fatty acids (n-3 PUFA)
Group II: Safflower OilActive Control3 Interventions
Omega-6 polyunsaturated fatty acids (n-6 PUFA)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fish Oil
2006
Completed Phase 4
~1320
Omega-3 polyunsaturated fatty acids
2017
Completed Phase 4
~330
Ethanol
2005
Completed Phase 4
~3000

Find a Location

Who is running the clinical trial?

Carsten Skarke, MDLead Sponsor
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,147 Total Patients Enrolled
Carsten Skarke, M.D.Principal InvestigatorInstitute for Translational Medicine & Therapeutics, SOM
Garret A FitzGerald, M.D.Principal InvestigatorInstitute for Translational Medicine & Therapeutics, School of Medicine

Media Library

Fish Oil (Omega-3 polyunsaturated fatty acid) Clinical Trial Eligibility Overview. Trial Name: NCT00682318 — N/A
Healthy Subjects Research Study Groups: Safflower Oil, Fish oil
Healthy Subjects Clinical Trial 2023: Fish Oil Highlights & Side Effects. Trial Name: NCT00682318 — N/A
Fish Oil (Omega-3 polyunsaturated fatty acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00682318 — N/A
~4 spots leftby Nov 2026
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