Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966755
• Other study ID #: HM20016253
• Status: Completed
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: May 11, 2023

Study information

• Verified date: May 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Normal Ejection Fraction
• Obesity

Intervention

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 .

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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