Status:
COMPLETED
Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Heart Failure With Normal Ejection Fraction
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, metaboli...
Detailed 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 i...
Eligibility Criteria
Inclusion
- Major
- 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
- 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
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03310099
Start Date
October 23 2017
End Date
October 4 2018
Last Update
April 18 2019
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298