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
Verified date | April 2019 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
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 |
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