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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310099
• Other study ID #: HM20011363
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: October 4, 2018

Study information

• Verified date: April 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 4, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Normal Ejection Fraction
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour dietary recall	Measured with validated 24-hour dietary recall (non-self administered)	Baseline to 12 weeks
Primary	Change in dietary compliance (biomarkers)	Measured by changes in biomarkers of unsaturated fatty acid consumption	Baseline to 12 weeks
Secondary	Change in metabolic flexibility	Area under the curve change of respiratory quotient measured during overnight stay for 14 hours in the WIC	At baseline and 12 weeks
Secondary	Change in body composition	Assessed by dual energy X-ray absorptiometry (DXA)	At baseline and at 12 weeks
Secondary	Change in glucose tolerance	Oral glucose tolerance test (OGTT) measures plasma glucose and insulin	At baseline and at 12 weeks