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NCT02514070 · ClinicalTrials.gov registry record · Phase 2
Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults
A Phase 2 study of Lipoprotein Metabolism and PCSK9, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT02514070: Completed Phase 2 study of Lipoprotein Metabolism and PCSK9, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02514070 is a Phase 2 study of Lipoprotein Metabolism and PCSK9 that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02514070, a Phase 2 study of Lipoprotein Metabolism and PCSK9, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are substances found in foods such as cold-water fish and shellfish that are essential for good health. Researchers want to see the effect of two fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on metabolism. They may be beneficial to cardiovascular health. Objective: \- To understand the effects of EPA and DHA on metabolism. Eligibility: \- Healthy people ages 18 years or above with plasma triglyceride (a type of fat in the blood) levels of 100 mg/dL or higher Design: * The study will last 20 to 24 weeks. * Participants will have 4 visits to the NIH Clinical Center. These will include: * Medical history * Physical Fasting blood and urine tests * CAVI tests: blood pressure is taken in the arms and legs, and the heart is monitored. * Participants will take an EPA/DHA dietary supplement. They will take 4 gel capsules, 3 times a day, for 6 or 7 weeks. Then they will not take the capsules for 8 to 10 weeks (a wash-out period). They will then take the capsules again for 6 or 7 weeks. * Participants will keep a food journal.
Primary Outcome
Measure plasma proprotein convertase subtilisin/kexin type 9 (PCSK9) level, at baseline, after 6 weeks of Eicosapentaenoic acid (EPA) or Docosahexaenoic acid (DHA) fish oil supplementation.
Conditions Studied
Interventions
- DRUG EPA-rich fish oil
- DRUG DHA-rich fish oil
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-10-30 |
| Est. Completion | 2019-07-23 |
| Phase | Phase 2 |
What the finished NCT02514070 record still lists
NCT02514070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 3 conditions, with Lipoprotein Metabolism appearing as the primary indexed condition, and to 2 interventions - of which EPA-rich fish oil is the first listed.
NCT02514070 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02514070 about?
NCT02514070 is a clinical study titled "Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults". Background: \- Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are substances found in foods such as cold-water fish and shellfish that are essential for good health. Researchers want to see the effect of two fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic...
What is the current status of trial NCT02514070?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2015-10-30. Estimated completion is 2019-07-23.
What conditions does trial NCT02514070 study?
This clinical trial studies the following conditions: Lipoprotein Metabolism, PCSK9, Proteomics.
What interventions are being tested in trial NCT02514070?
The interventions under investigation include: EPA-rich fish oil (DRUG), DHA-rich fish oil (DRUG).
Who is sponsoring clinical trial NCT02514070?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02514070 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
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