Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF (NCT03966755) | Clinical Trial Compass
CompletedNot Applicable
Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF
United States30 participantsStarted 2019-07-23
Plain-language summary
This study is designed to evaluate the effects of a diet rich in unsaturated fatty acids (UFA)-also known as 'healthy fats'-in patients with obesity and heart failure with preserved ejection fraction (HFpEF) on dietary consumption of UFA as well as fatty acids plasma levels.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Change in 24-hour dietary recall
Timeframe: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
2
Change in dietary compliance (biomarkers)
Timeframe: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks