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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT03310099

Collaborator

(none)

Enrollment

Location

Arm

11.4

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Normal Ejection Fraction Obesity	Behavioral: Increasing daily unsaturated fatty acid consumption	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

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 :

Oct 23, 2017

Actual Primary Completion Date :

Oct 4, 2018

Actual Study Completion Date :

Oct 4, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in 24-hour dietary recall [Baseline to 12 weeks]
Measured with validated 24-hour dietary recall (non-self administered)
Change in dietary compliance (biomarkers) [Baseline to 12 weeks]
Measured by changes in biomarkers of unsaturated fatty acid consumption

Secondary Outcome Measures

Change in metabolic flexibility [At baseline and 12 weeks]
Area under the curve change of respiratory quotient measured during overnight stay for 14 hours in the WIC
Change in body composition [At baseline and at 12 weeks]
Assessed by dual energy X-ray absorptiometry (DXA)
Change in glucose tolerance [At baseline and at 12 weeks]
Oral glucose tolerance test (OGTT) measures plasma glucose and insulin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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