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Effect of Omega-11 Enriched Fish Oil on Lipoprotein Metabolism
NCT03043365Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2017
- Primary completion
- May 2019
- Countries
- 1
- Sponsor
- National Heart, Lung, and Blood Institute
- Modality
- Classical Binding Small Molecules
- Drugs
- saury oil
- Conditions
- cardiovascular diseases (CVD)
01
Overview
Phase 2, randomised, double-blind trial of saury oil in cardiovascular diseases (CVD) (2 arms), sponsored by National Heart, Lung, and Blood Institute. Primary endpoint: Changes From Baseline in Lipid Profile at 8 weeks. Started Jun 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Control then Saury
Control Fish Oil for 8 weeks, Washout, then Saury Oil for 8 weeks
Saury then Control
Saury Oil for 8 weeks, Washout, then Control Fish Oil for 8 weeks
03
Who it enrols
Healthy volunteers aged 18 and older with no history of cardiovascular disease, not taking lipid-altering medications, and without significant liver or thyroid disease.
04
Endpoints
Primary
Changes From Baseline in Lipid Profile
Secondary
Changes Lipoprotein Particle Number, Composition and Size
Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein
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