UFA-Preserved2: Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03966755

Collaborator

American Heart Association (Other)

Enrollment

Location

Arms

41.3

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Heart Failure With Normal Ejection Fraction	Behavioral: UFA dietary recommendations	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 23, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UFA dietary recommendations Dietary intervention aimed at increasing UFA consumption.	Behavioral: UFA dietary recommendations 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 .
No Intervention: Standard dietary recommendations Standard of care dietary recommendations as currently performed in the clinic (2015-2020 United States Department of Agriculture (USDA) Dietary Guidelines for Americans)

Arm

Intervention/Treatment

Experimental: UFA dietary recommendations

Dietary intervention aimed at increasing UFA consumption.

Behavioral: UFA dietary recommendations

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 .

No Intervention: Standard dietary recommendations

Standard of care dietary recommendations as currently performed in the clinic (2015-2020 United States Department of Agriculture (USDA) Dietary Guidelines for Americans)

Outcome Measures

Primary Outcome Measures

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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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