Clinical trial NCT03966755: Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF
Official title: Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Patients With Obesity and Heart Failure With Preserved Ejection Fraction: The UFA-Preserved2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Heart Failure With Normal Ejection Fraction
Keywords: Obesity
Heart failure with Normal Ejection Fraction
HFpEF
unsaturated fatty acids
cardiorespiratory fitness
dietary intervention
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2019-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

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

Primary outcomes:
measure: Change in 24-hour dietary recall
timeFrame: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
measure: Change in dietary compliance (biomarkers)
timeFrame: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Salvatore Carbone, PhD
role: PRINCIPAL_INVESTIGATOR
References: