Effect of Omega 3 Fatty Acids on Vascular Function

NCT ID: NCT01888211

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Previous Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omega 3 fatty acid supplementation

Omacor 2 grams daily

Group Type EXPERIMENTAL

Omega 3 fatty acid supplementation

Intervention Type DIETARY_SUPPLEMENT

2 grams Omacor daily

Olive Oil

Olive Oil capsule 2 grams daily

Group Type PLACEBO_COMPARATOR

Olive Oil

Intervention Type DIETARY_SUPPLEMENT

2 grams olive oil daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omega 3 fatty acid supplementation

2 grams Omacor daily

Intervention Type DIETARY_SUPPLEMENT

Olive Oil

2 grams olive oil daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David E Newby

Role: STUDY_CHAIR

University of Edinburgh

Jehangir N Din

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Cardiovascular Sciences, University of Edinburgh

Edinburgh, Scotland, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LREC/2003/8/13

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.