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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hours to months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
~1370
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
324 Previous Clinical Trials
4,933,738 Total Patients Enrolled
Carsten Skarke, M.D.Principal InvestigatorInstitute for Translational Medicine & Therapeutics, SOM

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study accept applicants aged 25 and above?

"Patients must be between 21 and 60 years old to qualify for this trial. Notably, there are 55 studies exclusively for minors under 18, as well as 382 trials centered on seniors over the age of 65."

Answered by AI

How many individuals are participating in the current clinical trial?

"At this time, recruitment for the specified trial has been suspended. According to records on clinicaltrials.gov, it was first published 8th May 2008 with its latest edit occurring 9th March 2022. If you wish to explore other studies, there are presently 843 trials looking for healthy participants and 15 recruiting volunteers interested in Omega-3 polyunsaturated fatty acids treatments."

Answered by AI

Is this a pioneering trial that has never been attempted before?

"Presently, 15 clinical trials involving Omega-3 polyunsaturated fatty acids are ongoing in 14 cities and 6 governments. The inaugural study for this medication was conducted by Abbott back in 2005; it featured 15480 subjects and concluded its Phase 4 assessment. Since then, a further 209 have been finished successfully."

Answered by AI

Are there any unfilled slots for participants in this experiment?

"Per clinicaltrials.gov, this research initiative is no longer enrolling participants; the trial was initially posted in May 2008 and concluded March 2022. However, 858 other medical studies are currently recruiting patients presently."

Answered by AI

What therapeutic purposes are Omega-3 polyunsaturated fatty acids typically employed for?

"Omega-3 polyunsaturated fatty acids are a viable option to treat hypertriglyceridemia, as well as for nutritional supplementation, dietary and nutritional therapies, and pregnant or postnatal women."

Answered by AI

Who meets the criteria to partake in this research project?

"To be eligible for this medical experiment, individuals must possess a health status (HS) and meet the age prerequisite of 21-60. The study is aiming to admit approximately 40 volunteers."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers
Carsten Skarke, MD 2008. "Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00682318.
~1 spots leftby Nov 2024
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