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NCT00527436 · ClinicalTrials.gov registry record · NA
Fish Oil and Biomarkers of Cardiovascular Risk
A NA study, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT00527436 is a NA study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 3 participants.
The verdict
NCT00527436, a NA study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms underlying this cardioprotective effect are unknown but may involve favorable influences on various biomarkers of cardiovascular risk. In this project we will determine if these favorable effects of omega-3's occur in older healthy adults, as aging is a primary risk factor for cardiovascular disease development. Key Objectives To determine the effect of chronic (12 week) oral omega-3 fatty acid supplementation on biomarkers of cardiovascular risk in young and older adults. We hypothesize that omega-3 fatty acid supplementation will exert positive effects on biomarkers of cardiovascular risk. Study Population Healthy young (18-40 years of age) and older (50-79) men and women. Major Inclusion \& Exclusion Criteria Subjects must be healthy (as assessed by history and physical examination: non obese BMI\<30: normotensive BP \<140/90 mmHg) men and women not currently taking medications that could influence the results. Women must be non-pregnant. Normal liver enzymes (ALT and AST). Individuals with allergies to corn will be excluded. Allocation to Groups Randomized, double-blinded, and placebo-controlled. Summary of Procedures Measurements will be made at baseline and repeated \~12 weeks after beginning daily oral ingestion of either low dose or high dose fish oil capsules or placebo
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT fish oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-09 |
| Est. Completion | 2007-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00527436
The ClinicalTrials.gov registry entry for NCT00527436 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00527436 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00527436 about?
NCT00527436 is a clinical study titled "Fish Oil and Biomarkers of Cardiovascular Risk". Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms underlying this cardioprotective...
What is the current status of trial NCT00527436?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2007-09. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00527436?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), fish oil (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00527436?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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