Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients

NCT ID: NCT03310099

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2018-10-04

Brief Summary

The investigators hypothesize that a dietary intervention aimed at increasing unsaturated fatty acids (UFA) consumption is feasible and has the potential to improve cardiorespiratory fitness, metabolic flexibility and glucose tolerance in symptomatic obese heart failure with preserved ejection fraction (HFpEF) patients.

Detailed Description

Twelve obese HFpEF subjects with exercise intolerance (reduce cardiorespiratory fitness measured at maximal cardiopulmonary exercise test [CPX]) will be assigned to a single-arm open-label dietary intervention in which subjects are encouraged and financially supported to increase daily UFA consumption. The investigators will measure dietary compliance with a validated 24-hour dietary recall and with objective operator-independent biomarkers of UFA consumption.

The investigators will also measure the effects of UFA supplementation on: metabolic flexibility, glucose tolerance and body composition. Participants will have the option to participate in overnight session in the whole indirect calorimeter room (WIC) at baseline and at the end of the study.

Conditions

Heart Failure With Normal Ejection Fraction; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dietary Intervention

Dietary intervention aimed at increasing UFA consumption. 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 \[MUFA\] 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 .

Group Type: EXPERIMENTAL

Increasing daily unsaturated fatty acid consumption

Intervention Type: BEHAVIORAL

Investigators will provide participant with detailed information about the consumption of food rich in unsaturated fatty acids (UFA) like extra-virgin olive oil, canola oil or mixed nuts, and they will provide specific recommendations based on the participant's diet. The investigators will follow up with a weekly phone call to assure that the dietary recommendations are clear and that the participants can integrate the suggestions into their daily diets.

Interventions

Increasing daily unsaturated fatty acid consumption

Investigators will provide participant with detailed information about the consumption of food rich in unsaturated fatty acids (UFA) like extra-virgin olive oil, canola oil or mixed nuts, and they will provide specific recommendations based on the participant's diet. The investigators will follow up with a weekly phone call to assure that the dietary recommendations are clear and that the participants can integrate the suggestions into their daily diets.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore Carbone, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20011363

Identifier Type: -

Identifier Source: org_study_id