Effect of Omega 3 Fatty Acids on Vascular Function

NCT01888211 | Completed

• 1 other identifier: LREC/2003/8/13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Previous Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Endogenous fibrinolysis (net release of plasma t-PA,IU mL-1)

  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.

  Measured at 6 weeks after omega 3 fatty acids or placebo

Secondary Outcomes (2)

• Endothelial vasomotor function (forearm blood flow, mL l00 mL-1 min-1)

  Measured at 6 weeks after omega 3 fatty acids or placebo

• Circulating platelet-monocyte aggregates (%).

  Measured at 6 weeks after omega 3 fatty acids or placebo

Study Arms (2)

Omega 3 fatty acid supplementation

EXPERIMENTAL

Omacor 2 grams daily

Dietary Supplement: Omega 3 fatty acid supplementation

Olive Oil

PLACEBO COMPARATOR

Olive Oil capsule 2 grams daily

Dietary Supplement: Olive Oil

Interventions

Omega 3 fatty acid supplementation DIETARY_SUPPLEMENT

2 grams Omacor daily

Omega 3 fatty acid supplementation

Olive Oil DIETARY_SUPPLEMENT

2 grams olive oil daily

Olive Oil

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Myocardial infarction at least 3 months previously.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Centre for Cardiovascular Sciences, University of Edinburgh

Edinburgh, Scotland, EH16 4SB, United Kingdom

Location

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David E Newby

  University of Edinburgh

  STUDY CHAIR

• Jehangir N Din

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 27, 2013
• Study Start: December 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2009
• Last Updated: May 1, 2024

Record last verified: 2013-06

Locations

GB (1)