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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03310099
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : September 20, 2018
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Heart Failure With Normal Ejection Fraction Obesity Behavioral: Increasing daily unsaturated fatty acid consumption Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients: a Feasibility Study
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Arm Intervention/treatment
Experimental: 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 .
Behavioral: 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.

Primary Outcome Measures :
  1. Change in 24-hour dietary recall [ Time Frame: Baseline to 12 weeks ]
    Measured with validated 24-hour dietary recall (non-self administered)

  2. Change in dietary compliance (biomarkers) [ Time Frame: Baseline to 12 weeks ]
    Measured by changes in biomarkers of unsaturated fatty acid consumption

Secondary Outcome Measures :
  1. Change in metabolic flexibility [ Time Frame: At baseline and 12 weeks ]
    Area under the curve change of respiratory quotient measured during overnight stay for 14 hours in the WIC

  2. Change in body composition [ Time Frame: At baseline and at 12 weeks ]
    Assessed by dual energy X-ray absorptiometry (DXA)

  3. Change in glucose tolerance [ Time Frame: At baseline and at 12 weeks ]
    Oral glucose tolerance test (OGTT) measures plasma glucose and insulin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03310099

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Contact: Salvatore Carbone, PhD (804) 628-3980
Contact: Hayley Billingsley, RD (804) 628-3981

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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Antonio Abbate, MD, PhD    804-828-0513   
Contact: Salvatore Carbone, PhD    (804) 628-3980   
Sponsors and Collaborators
Virginia Commonwealth University
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Principal Investigator: Salvatore Carbone, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University Identifier: NCT03310099     History of Changes
Other Study ID Numbers: HM20011363
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Commonwealth University:
Heart failure with preserved ejection fraction
unsaturated fatty acids
cardiorespiratory fitness
dietary intervention

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases