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NCT00682318 · ClinicalTrials.gov registry record · NA
Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers
A NA study of Healthy, sponsored by Carsten Skarke, MD.
- Active
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00682318: Active NA study of Healthy, sponsored by Carsten Skarke, MD.
NCT00682318 is a NA study of Healthy that is active but no longer recruiting, run by Carsten Skarke, MD. The registered enrollment target is 40 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00682318, a NA study of Healthy, is active but no longer recruiting, sponsored by Carsten Skarke, MD.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
urinary isoprostanes will be analyzed raw (i.e. untransformed, including the Time factor: Baseline vs Peak)
Conditions Studied
Interventions
- DRUG Fish Oil
- DIETARY_SUPPLEMENT Safflower Oil
- DIETARY_SUPPLEMENT Ethanol
- DIETARY_SUPPLEMENT Omega-3 polyunsaturated fatty acids
- DIETARY_SUPPLEMENT Omega-6 polyunsaturated fatty acid
Study Locations (1)
Pennsylvania
- Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-05 |
| Est. Completion | 2029-11 |
| Phase | NA |
What the registry record for NCT00682318 still lists
NCT00682318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 5 interventions - of which Fish Oil is the first listed.
NCT00682318 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00682318 about?
NCT00682318 is a clinical study titled "Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers". 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 neces...
What is the current status of trial NCT00682318?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2008-05. Estimated completion is 2029-11.
What conditions does trial NCT00682318 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00682318?
The interventions under investigation include: Fish Oil (DRUG), Safflower Oil (DIETARY_SUPPLEMENT), Ethanol (DIETARY_SUPPLEMENT), Omega-3 polyunsaturated fatty acids (DIETARY_SUPPLEMENT), Omega-6 polyunsaturated fatty acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00682318?
This trial is sponsored by Carsten Skarke, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00682318 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00682318's enrollment target sits among peer trials
40 540th of 1090 higher than 513 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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