Heart Failure With Normal Ejection Fraction, Obesity
Conditions
Keywords
Obesity, Heart failure with preserved ejection fraction, HFpEF, unsaturated fatty acids, cardiorespiratory fitness, dietary intervention
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, metabolic flexibility and glucose tolerance in symptomatic obese heart failure with preserved ejection fraction (HFpEF) patients.
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 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.
Interventions
BEHAVIORALIncreasing daily unsaturated fatty acid consumption
Investigators will provide participant with detailed information about the consumption of food rich in unsaturated fatty acids (UFA) like extra-virgin olive oil, canola oil or mixed nuts, and they will provide specific recommendations based on the participant's diet. The investigators will follow up with a weekly phone call to assure that the dietary recommendations are clear and that the participants can integrate the suggestions into their daily diets.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour dietary recall | Baseline to 12 weeks | Measured with validated 24-hour dietary recall (non-self administered) |
| Change in dietary compliance (biomarkers) | Baseline to 12 weeks | Measured by changes in biomarkers of unsaturated fatty acid consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in metabolic flexibility | At baseline and 12 weeks | Area under the curve change of respiratory quotient measured during overnight stay for 14 hours in the WIC |
| Change in body composition | At baseline and at 12 weeks | Assessed by dual energy X-ray absorptiometry (DXA) |
| Change in glucose tolerance | At baseline and at 12 weeks | Oral glucose tolerance test (OGTT) measures plasma glucose and insulin |
Countries
United States
Outcome results
None listed