Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in dietary compliance (biomarkers)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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 .
干预措施: Increasing daily unsaturated fatty acid consumption (Behavioral)
结局指标
主要结局
Change in dietary compliance (biomarkers)
时间窗: Baseline to 12 weeks
Measured by changes in biomarkers of unsaturated fatty acid consumption
Change in 24-hour dietary recall
时间窗: Baseline to 12 weeks
Measured with validated 24-hour dietary recall (non-self administered)
次要结局
- Change in body composition(At baseline and at 12 weeks)
- Change in metabolic flexibility(At baseline and 12 weeks)
- Change in glucose tolerance(At baseline and at 12 weeks)