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

Primary Purpose

Heart Failure With Normal Ejection Fraction, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Increasing daily unsaturated fatty acid consumption

About this trial

This is an interventional treatment trial for Heart Failure With Normal Ejection Fraction focused on measuring Obesity, Heart failure with preserved 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 Type

Experimental

Arm Label

Dietary Intervention

Arm Description

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 .

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

Change in metabolic flexibility

Area under the curve change of respiratory quotient measured during overnight stay for 14 hours in the WIC

Change in body composition

Assessed by dual energy X-ray absorptiometry (DXA)

Change in glucose tolerance

Oral glucose tolerance test (OGTT) measures plasma glucose and insulin

Full Information

NCT ID

NCT03310099

First Posted

October 2, 2017

Last Updated

April 16, 2019

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT03310099

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

October 23, 2017 (Actual)

Primary Completion Date

October 4, 2018 (Actual)

Study Completion Date

October 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

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

Heart Failure With Normal Ejection Fraction, Obesity

Keywords

Obesity, Heart failure with preserved ejection fraction, HFpEF, unsaturated fatty acids, cardiorespiratory fitness, dietary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dietary Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Increasing daily unsaturated fatty acid consumption

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in 24-hour dietary recall

Description

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

Time Frame

Baseline to 12 weeks

Title

Change in dietary compliance (biomarkers)

Description

Measured by changes in biomarkers of unsaturated fatty acid consumption

Time Frame

Baseline to 12 weeks

Secondary Outcome Measure Information:

Title

Change in metabolic flexibility

Description

Area under the curve change of respiratory quotient measured during overnight stay for 14 hours in the WIC

Time Frame

At baseline and 12 weeks

Title

Change in body composition

Description

Assessed by dual energy X-ray absorptiometry (DXA)

Time Frame

At baseline and at 12 weeks

Title

Change in glucose tolerance

Description

Oral glucose tolerance test (OGTT) measures plasma glucose and insulin

Time Frame

At baseline and at 12 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

IPD Sharing Plan Description

The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.

Learn more about this trial

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

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