Effect of Omega 3 Fatty Acids on Vascular Function

Not Applicable

Completed

• Conditions: Previous Myocardial Infarction
• Interventions: Dietary Supplement: Olive Oil; Dietary Supplement: Omega 3 fatty acid supplementation

• Registration Number: NCT01888211
• Lead Sponsor: University of Edinburgh

Brief Summary

The mechanisms through which omega-3 fatty acids reduce adverse cardiac events remain uncertain. The aim of the study was to investigate the effect of omega-3 fatty acid supplementation on endothelial vasomotor function, endogenous fibrinolysis, and platelet and monocyte activation in patients with coronary heart disease.

Detailed Description

Twenty patients with a previous myocardial infarction were recruited into a randomised, double-blind, placebo-controlled, crossover trial of omega-3 fatty acid supplementation (2g/day for 6-weeks). Peripheral blood was taken for analysis of platelet and monocyte activation, and forearm blood flow was assessed in a subset of 12 patients during intrabrachial infusions of acetylcholine, substance P and sodium nitroprusside. Stimulated plasma tissue plasminogen activator (t-PA) concentrations were measured during substance P infusion.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-06
• Study Completion: 2009-06
• Status Verified: 2013-06
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-27
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Myocardial infarction at least 3 months previously.

Exclusion Criteria

• Dietary fish allergy or intolerance
• Women of child bearing potential
• Malignant arrhythmias
• Renal or hepatic failure
• Severe or significant co-morbidity
• Previous history of blood dyscrasia
• Unable to tolerate the supine position
• Lack of informed consent
• Blood donation within last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Olive Oil	Olive Oil	Olive Oil capsule 2 grams daily
Omega 3 fatty acid supplementation	Omega 3 fatty acid supplementation	Omacor 2 grams daily

Primary Outcome Measures

Name	Time	Method
Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1)	Measured at 6 weeks after omega 3 fatty acids or placebo	Endogenous fibrinolysis was measured by drawing blood during intrabrachial substance P infusion and then plasma t-PA antigen and activity (t-PA Combi Actibind Elisa Kit; Technoclone, Vienna, Austria) concentrations were determined by enzyme-linked immunosorbent assays. Estimated net release of plasma t-PA was the product of the infused forearm plasma flow (based on the mean hematocrit and the infused forearm blood flow) and the concentration difference between the infused and noninfused arms.

Secondary Outcome Measures

Name	Time	Method
Endothelial vasomotor function (forearm blood flow, mL l00 mL-1 min-1)	Measured at 6 weeks after omega 3 fatty acids or placebo	Forearm blood flow was measured during intrabrachial infusions of acetylcholine, substance P and sodium nitroprusside by venous occlusion plethysmography with mercury-in-silicone elastomer strain gauges.
Circulating platelet-monocyte aggregates (%).	Measured at 6 weeks after omega 3 fatty acids or placebo	Whole blood was immunolabelled with appropriate monoclonal antibodies for subsequent flow cytometric analysis of platelet-monocyte aggregation. Platelet-monocyte aggregates were defined as the percentage of monocytes positive for CD42a.

Trial Locations

Locations (1)

Centre for Cardiovascular Sciences, University of Edinburgh; 🇬🇧 Edinburgh, Scotland, United Kingdom