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NCT03043365 · ClinicalTrials.gov registry record · Phase 2
Effect of Fish Oil Enriched In Omega-11 Fatty Acid 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
- 37
- Enrollment target
- 1
- Study location
NCT03043365 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 37 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03043365, 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
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3 fatty acid is the most known fish oil available in the market. LCMUFA (long-chain monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched fish oil and understand its effect on cardiovascular health. Objective: To understand the effects of LCMUFA from fish oil on cardiovascular health. Eligibility: Healthy volunteers ages 18 and older with no history of cardiovascular disease Design: Participants will be screened with: * Medical history * Physical exam * Fasting blood and urine tests * Optional stool sample * Questions about their diet, exercise, and the types of medicines and dietary supplements they take * 7-day food diary * Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The heart is monitored. * After the screening visit, participants will take 4 gel capsules, 3 times a day after meals, for 8-10 weeks. * Electrocardiogram (EKG) Participants will have 3 additional visits. All include repeats of the screening tests. Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for 8 weeks after this visit. Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4 capsules, 3 times a day after meals, for 8 weeks after this visit. Visit 4 is 8 weeks after starting the second supplement.
Conditions Studied
Interventions
- DRUG control fish oil
- DRUG LCMUFA-rich saury oil
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-06-15 |
| Est. Completion | 2019-11-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03043365
The ClinicalTrials.gov registry entry for NCT03043365 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Lipoprotein Metabolism appearing as the primary indexed condition, and to 2 interventions - of which control fish oil is the first listed.
NCT03043365 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03043365 about?
NCT03043365 is a clinical study titled "Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults". Background: Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3 fatty acid is the most known fish oil available in the market. LCMUFA (long-chain monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a diet rich in omega-1...
What is the current status of trial NCT03043365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2017-06-15. Estimated completion is 2019-11-21.
What conditions does trial NCT03043365 study?
This clinical trial studies the following conditions: Lipoprotein Metabolism, PCSK9, Proteomics.
What interventions are being tested in trial NCT03043365?
The interventions under investigation include: control fish oil (DRUG), LCMUFA-rich saury oil (DRUG).
Who is sponsoring clinical trial NCT03043365?
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 NCT03043365 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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