Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF

NCT03966755 | Completed

• 1 other identifier: HM20016253
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Heart Failure With Normal Ejection Fraction

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

UFA dietary recommendations

EXPERIMENTAL

Dietary intervention aimed at increasing UFA consumption.

Behavioral: UFA dietary recommendations

Standard dietary recommendations

NO INTERVENTION

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

Interventions

UFA dietary recommendations BEHAVIORAL

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 .

UFA dietary recommendations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Heart Association: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvatore Carbone, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: July 23, 2019
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)