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

Primary Purpose

Obesity, Heart Failure With Normal Ejection Fraction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

UFA dietary recommendations

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Heart failure with Normal Ejection Fraction, HFpEF, unsaturated fatty acids, cardiorespiratory fitness, dietary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

UFA dietary recommendations

Standard dietary recommendations

Arm Description

Dietary intervention aimed at increasing UFA consumption.

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

Outcomes

Primary Outcome Measures

Change in 24-hour dietary recall

Measured with validated 24-hour dietary recall (non-self administered)

Change in dietary compliance (biomarkers)

Measured by changes in biomarkers of unsaturated fatty acid consumption

Secondary Outcome Measures

Full Information

NCT ID

NCT03966755

First Posted

May 24, 2019

Last Updated

May 18, 2023

Sponsor

Virginia Commonwealth University

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT03966755

Brief Title

Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF

Acronym

UFA-Preserved2

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

July 23, 2019 (Actual)

Primary Completion Date

May 11, 2023 (Actual)

Study Completion Date

May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Heart Failure With Normal Ejection Fraction

Keywords

Obesity, Heart failure with Normal Ejection Fraction, HFpEF, unsaturated fatty acids, cardiorespiratory fitness, dietary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UFA dietary recommendations

Arm Type

Experimental

Arm Description

Dietary intervention aimed at increasing UFA consumption.

Arm Title

Standard dietary recommendations

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

UFA dietary recommendations

Intervention Description

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 .

Primary Outcome Measure Information:

Title

Change in 24-hour dietary recall

Description

Measured with validated 24-hour dietary recall (non-self administered)

Time Frame

At baseline, at 12 weeks, at 18 weeks, and at 30 weeks

Title

Change in dietary compliance (biomarkers)

Description

Measured by changes in biomarkers of unsaturated fatty acid consumption

Time Frame

At baseline, at 12 weeks, at 18 weeks, and at 30 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salvatore Carbone, PhD

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF

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