Heart Disease Clinical Trial
Official title:
Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.
The safety profile of omega-3 fatty acids is considered to be excellent, and has been
recognized as safe (GRAS) by the US Food and Drug Administration when EPA and DHA
(docosahexanoic acid) are given together at a dose of 3 grams/day or less. Safety will be
monitored by assessing for adverse reactions, measuring vital signs and a variety of
laboratory tests including a complete metabolic profile and complete blood count. Efficacy
will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.
The goal of this study is to test this EPA oil at doses of 600 mg and 1800 mg of EPA/day as
compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk
period. In a parallel arm study design, 120 healthy adults will be randomized to one of four
groups (30 in each group) and studied in both the fasting and post-prandial state.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03481322 -
Low Sodium Cooking Study
|
N/A | |
| Completed |
NCT00001638 -
Magnetic Resonance Imaging of the Blood Vessels of the Heart
|
||
| Completed |
NCT02376244 -
The Health Impact of High Intensity Exercise Training With Intervals During Cardiac Rehabilitation
|
N/A | |
| Completed |
NCT02523144 -
Dexmedetomidine in Children Having Transthoracic Echocardiography
|
Phase 4 | |
| Completed |
NCT02277379 -
Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery
|
N/A | |
| Completed |
NCT02045641 -
Pleural and Pericardial Effusion Following Open Heart Surgery
|
N/A | |
| Completed |
NCT01871090 -
Remote Device Interrogation In The Emergency Department
|
N/A | |
| Active, not recruiting |
NCT01400490 -
Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study
|
N/A | |
| Completed |
NCT01192360 -
Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease
|
Phase 3 | |
| Terminated |
NCT00935766 -
Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries
|
Phase 3 | |
| Completed |
NCT00745446 -
The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation
|
N/A | |
| Completed |
NCT00140816 -
Dairy Products and Metabolic Effects (Norwegian Part)
|
N/A | |
| Completed |
NCT00178620 -
Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization
|
Phase 4 | |
| Completed |
NCT00013949 -
Cardiovascular Vulnerability to Particulate Exposure
|
N/A | |
| Completed |
NCT01952171 -
The Genetic Basis of Congenital Heart Disease in Africa
|
||
| Recruiting |
NCT02933892 -
Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization
|
Phase 4 | |
| Withdrawn |
NCT02838355 -
Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients
|
N/A | |
| Completed |
NCT02923518 -
Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
|
||
| Terminated |
NCT02282163 -
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
|
Phase 3 | |
| Active, not recruiting |
NCT02260466 -
Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement.
|
N/A |