Examining the Effects of High Protein Diet on Outcomes in Heart Failure Patients

检查高蛋白饮食对心力衰竭患者预后的影响

基本信息

批准号：
7915297
负责人：
LORRAINE S EVANGELISTA
金额：
$ 18.79万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-08-17 至 2010-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7915297
关键词：
Address Adherence Adult Affect American American Heart Association Americas Biochemical Biological Preservation Blood Glucose Body Composition Body Weight Body Weight decreased Body fat Body mass index Caliber Carbohydrates Cardiac Cardiology Cardiomyopathies Cardiopulmonary Cardiovascular Diseases Cessation of life Cholesterol Chronic Clinical Clinical Trials Counseling Data Data Analyses Development Diabetes Mellitus Diagnosis Diet Diet Modification Diet and Nutrition Dietary Intervention Dietary Practices Disease Disease Progression Effectiveness Emotional Etiology European Exercise Exercise stress test Fasting Fatty acid glycerol esters Goals Guidelines Heart Heart Transplantation Heart failure High Density Lipoprotein Cholesterol Homeostasis Hypertriglyceridemia Individual Insulin Resistance Intake Intervention LDL Cholesterol Lipoproteins Lipids Long-Term Effects Macronutrients Nutrition Maintenance Malnutrition Measurement Measures Metabolic Methods Modality Modeling Monitor Morbidity - disease rate NIH Program Announcements Nature New York Non-Insulin-Dependent Diabetes Mellitus Nutritional Obesity Outcome Participant Patient Self-Report Patients Pharmaceutical Preparations Physical activity Physicians Plasma Prevention Proteins Quality of life Randomized Randomized Clinical Trials Recommendation Reporting Research Personnel Research Support Risk Role Societies Specific qualifier value Structure Subgroup Symptoms Testing Time Transplantation Triad Acrylic Resin Two-Dimensional Doppler Echocardiography United States National Institutes of Health Update Walking Weight arm biobehavior college community setting design diabetic patient dosage functional disability functional status glycemic control hemodynamics improved indexing mortality nutrition post intervention prospective response waist circumference weight loss intervention weight maintenance working group

项目摘要

Heart failure (HF), obesity, and diabetes mellitus (DM) often co-exist and are associated with the development and progression of cardiovascular disease, functional disability, increased symptoms, and diminished quality of life (QOL). Nutritional management of HF, obesity, and DM is poorly understood and little guidance is available regarding dietary approaches for these patients. The proposed study is designed to test the effects of a high protein (HP) diet vs. a standard protein (SP) diet on adiposity, cardiac structure, functional status, lipid profiles, glycemic control, insulin resistance, and QOL in 90 patients with HF, New York Heart Association class II and III, body mass index (BMI)  30 kg/m2, and DM. A prospective, two-group, randomized design will be used to test the study hypotheses. Participants will be randomized to either a HP or SP diet. The prescribed HP diet consists of 30% of energy from protein (110 g/day), 40% of energy from carbohydrate (CHO; 150 g/day) and 30% from fat (50 g/day), while the SP diet consists of 15% of energy from protein (55 g/day), 55% of energy from CHO (200 g/day) and 30% from fat (50 g/day). Patients in the 2 study arms will participate in an intensive 12-week supervised weight loss intervention during which they will receive personalized nutritional counseling and support at baseline and asked to return at 1, 2, 4, 8, and 12 weeks. Patients will be encouraged to engage in 20-30 minutes of physical activity, such as walking, three to five days per week and gradually increase to 30-60 minutes daily to promote energy deficit and facilitate weight loss. After the 3-month dietary intervention, participants will be instructed to continue the same dietary pattern followed during the previous 12 weeks of the study (maintenance). They will be seen every 3 months for one year (weeks 24, 36, 48, and 60) to monitor weight maintenance. Weight, BMI, waist circumference, dual-energy x-ray absorptiometry, 2D and Doppler echocardiography, cardiopulmonary exercise stress testing, six minute walk test, biochemical analyses (plasma lipid profiles, fasting blood sugar, and homeostasis model assessment), and self-reported measures of QOL will be completed at 3 measurement periods: baseline, immediately after the 3-month dietary intervention (12-weeks), and one year post intervention (60 weeks). The overall goal of the study is to test the hypothesis that a HP diet will result in significantly greater reductions in adiposity and greater improvements in cardiac structure, functional status, lipid profiles, glycemic control and insulin resistance, and QOL following the 3-month intervention and that these changes will be maintained over time. Mixed models will be used to analyze the data. Data from the proposed study will provide researchers and clinicians with a better understanding of the biobehavioral underpinnings associated with obesity, HP diets, and weight loss outcomes. This information will provide evidence for rational recommendations for weight loss modalities that can be integrated in HF management and treatment guidelines.

心力衰竭 (HF)、肥胖和糖尿病 (DM) 经常共存，并与心血管疾病、功能障碍、症状加重和生活质量 (QOL) 下降相关。我们对肥胖和糖尿病知之甚少，并且对于这些患者的饮食方法也缺乏指导。拟议的研究旨在测试高蛋白 (HP) 饮食与标准蛋白 (SP) 饮食对肥胖、心脏结构的影响。 , 功能状态, 血脂一项前瞻性、两组、随机设计将评估 90 名 HF、纽约心脏协会 II 级和 III 级、体重指数 (BMI) ≥ 30 kg/m2 和 DM 患者的概况、血糖控制、胰岛素抵抗和生活质量。用于检验研究假设。参与者将被随机分配到 HP 或 SP 饮食中。规定的 HP 饮食包含 30% 的能量来自蛋白质（110 克/天），40% 的能量来自碳水化合物。（CHO；150 克/天）和 30% 来自脂肪（50 克/天），而 SP 饮食则包含 15% 的能量来自蛋白质（55 克/天）、55% 的能量来自 CHO（ 200 克/天）和 30% 来自脂肪（50 克/天），两个研究组的患者将在期间参加为期 12 周的强化监督减肥干预。他们将在基线时接受个性化的营养咨询和支持，并要求在第 1、2、4、8 和 12 周时返回，鼓励患者进行 20-30 分钟的体力活动，例如步行、3 至 5 周。每周几天，并逐渐增加到每天 30-60 分钟，以促进能量不足并促进减肥。经过 3 个月的饮食干预后，参与者将被指示继续在研究的前 12 周遵循相同的饮食模式。（维持）。一年内（第 24、36、48 和 60 周）每 3 个月进行一次，以监测体重维持情况、BMI、腰围、双能 X 射线吸收测定法、2D 和多普勒超声心动图。心肺运动压力测试、六分钟步行测试、生化分析（血浆脂质谱、空腹血糖和稳态模型评估）以及自我报告的测量QOL 将在 3 个测量期完成：基线、3 个月饮食干预后立即（12 周）和干预后一年（60 周）。该研究的总体目标是检验 HP 饮食的假设。经过 3 个月的干预后，将导致肥胖更显着减少，心脏结构、功能状态、血脂状况、血糖控制和胰岛素抵抗以及生活质量得到更大改善，并且这些变化将随着时间的推移而保持。来分析数据。拟议研究的数据将使研究人员和反叛者更好地了解与肥胖、HP 饮食和减肥结果相关的生物行为基础。这些信息将为合理推荐可纳入心力衰竭管理和减肥的方法提供证据。治疗指南。