Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will evaluate participant's food consumption during 2 different 12-week periods. During one of the 12-week periods, participants will receive specific counseling and instructions on how to increase the consumption of food rich in healthy fats; during the other 12-week period they will receive general dietary recommendations following the Dietary Guidelines for Americans. There will be a 6-week break (washout) between the 12-week periods for a total of study period of 30 weeks. During each 12-week periods, the study will measure the effects of these dietary recommendations on dietary consumption and the fatty acids in their blood (primary endpoints).

Official Title
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Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Patients With Obesity and Heart Failure With Preserved Ejection Fraction: The UFA-Preserved2 Study

Conditions
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Obesity, Heart Failure With Normal Ejection Fraction

Intervention / Treatment
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* Behavioral: UFA dietary recommendations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UFA dietary recommendations<br>Dietary intervention aimed at increasing UFA consumption. | Behavioral: UFA dietary recommendations<br>* The face-to-face intervention will be performed by a research nutritionist that reviews the dietary recall and provides a list of commonly available foods rich in unsaturated fatty acids (UFA) (monounsaturated fatty acids (MUFA) and polyunsaturated fatty acids (PUFA)), together with individual instructions on how to integrate the recommended foods in the daily dietary pattern based on the dietary recall, and also to emphasize that the recommended food should be consumed as listed, and not as part of processed food (i.e., guacamole for avocado, hazelnut chocolate for nuts, pesto for olive oil, fish sticks for fatty fish). Extra-virgin olive oil or canola oil or nuts will be considered first choice for daily consumption of UFA-rich food, but a list of daily food substitutes will be also provided .<br>|
| No Intervention: Standard dietary recommendations<br>Standard of care dietary recommendations as currently performed in the clinic (2015-2020 United States Department of Agriculture (USDA) Dietary Guidelines for Americans) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour dietary recall | Measured with validated 24-hour dietary recall (non-self administered) | At baseline, at 12 weeks, at 18 weeks, and at 30 weeks | 
| Change in dietary compliance (biomarkers) | Measured by changes in biomarkers of unsaturated fatty acid consumption | At baseline, at 12 weeks, at 18 weeks, and at 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Heart failure with Normal Ejection Fraction, HFpEF, unsaturated fatty acids, cardiorespiratory fitness, dietary intervention