At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Do Innovative Strategies Complement Medical Management to Reduce Cardiovascular Risk Factors Following Coronary Artery Bypass Graft Surgery?
In Brief
A Phase 2 clinical trial evaluating Consumption of Dietary Portfolio for Coronary Artery Disease and Type II Diabetes Mellitus. Completed, enrolled 35 participants across 1 site.
Detailed Summary
Background: Treatment targets for cardiac risk factor reduction are not being met. Therefore, there is a need for new strategies to assist patients in meeting these goals. Objective: To determine the amount of any additional benefit on risk factor reduction associated with the consumption of the "dietary portfolio" (a low fat diet with soy, nuts and viscous fibres), above that achieved with medical management in diabetic patients following cardiac surgery. Description: 35 cardiac surgery patients with diabetes will be instructed on how to incorporate the dietary portfolio foods into their diet for four weeks. Changes in blood cholesterol, markers of inflammation, blood sugar control and modifiable risk factors will be assessed after 2 and 4 weeks of therapy. Relevance: Maximizing cardiac risk factor reduction through a combined approach (dietary plus medication) should improve outcomes, reduce rates of re-hospitalization and improve quality of life in diabetic patients after heart surgery.
Study Details
Timeline
Interventions
The study involves following an aggressive low fat diet that is high in viscous fiber, nuts and soy protein. The diet is individually tailored to meet individual participants needs.