Heart Failure Clinical Trial

Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients

Summary

The investigators hypothesize that a dietary intervention aimed at increasing unsaturated fatty acids (UFA) consumption is feasible and has the potential to improve cardiorespiratory fitness, metabolic flexibility and glucose tolerance in symptomatic obese heart failure with preserved ejection fraction (HFpEF) patients.

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Full Description

Twelve obese HFpEF subjects with exercise intolerance (reduce cardiorespiratory fitness measured at maximal cardiopulmonary exercise test [CPX]) will be assigned to a single-arm open-label dietary intervention in which subjects are encouraged and financially supported to increase daily UFA consumption. The investigators will measure dietary compliance with a validated 24-hour dietary recall and with objective operator-independent biomarkers of UFA consumption.

The investigators will also measure the effects of UFA supplementation on: metabolic flexibility, glucose tolerance and body composition. Participants will have the option to participate in overnight session in the whole indirect calorimeter room (WIC) at baseline and at the end of the study.

View Eligibility Criteria

Eligibility Criteria

Major Inclusion Criteria:

Body Mass Index (BMI) ≥30 kg/m2 (obesity) or total body fat percentage >25% in men and >35% in women
A confirmed clinical diagnosis of stable HF (New York Heart Association [NYHA] class II-III) on maximally tolerated heart failure (HF) optimal medical regimen (without major changes in the prior month)
Left Ventricular Ejection Fraction (LVEF)>50% documented in the prior 12 months

Major Exclusion Criteria:

Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e.,physical inability to walk or run on treadmill);
Significant ischemic heart disease, angina, uncontrolled arterial hypertension, atrial fibrillation, moderate to severe valvular disease, chronic pulmonary disease, anemia (Hemoglobin<10 g/dL)
Electrocardiography (ECG) changes (ischemia or arrhythmias) that limit maximum exertion during cardiopulmonary exercise test
Comorbidity limiting survival
Stage IV-V kidney disease (estimated Glomerular Filtration Rate<30)
Fluid overload
Pregnancy
Current use of unsaturated fatty acids (UFA) supplement (i.e., omega-3).
Inability to give informed consent

Study is for people with:

Heart Failure

Estimated Enrollment:

16

Study ID:

NCT03310099

Recruitment Status:

Completed

Sponsor:

Virginia Commonwealth University

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There is 1 Location for this study

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Virginia Commonwealth University
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

16

Study ID:

NCT03310099

Recruitment Status:

Completed

Sponsor:


Virginia Commonwealth University

How clear is this clinincal trial information?

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