Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF

Not Applicable

Completed

• Conditions: Obesity; Heart Failure With Normal Ejection Fraction
• Interventions: Behavioral: UFA dietary recommendations

• Registration Number: NCT03966755
• Lead Sponsor: Virginia Commonwealth University

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).

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Study Start: 2019-07-23
• Primary Completion: 2023-05-11
• Study Completion: 2023-05-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UFA dietary recommendations	UFA dietary recommendations	Dietary intervention aimed at increasing UFA consumption.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States