Nutritional Therapy in Elderly with Heart Failure

老年心力衰竭的营养治疗

• 批准号: 8905904
• 负责人: ROBERT R WOLFE
• 金额: $ 14.97万
• 依托单位: ESSENTIAL BLENDS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-15 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8905904
• 关键词: Activities of Daily Living; Address; Amino Acids; Arginine; Behavior; Beverages; Blood Vessels; Carbohydrates; Carbon Dioxide; Cardiac; Clinical Trials; Controlled Clinical Trials; Development; Drug Formulations; Elderly; Energy Metabolism; Essential Amino Acids; Exercise; Goals; Health; Heart failure; Impairment; Individual; Insulin; Insulin Resistance; Marketing; Metabolic; Metabolism; Morbidity - disease rate; Muscle Cells; Muscle Fatigue; Muscle Proteins; Muscle Weakness; Muscle function; Nature; Nitric Oxide; Nutritional; Nutritional Support; Obesity; Outcome; Oxygen; Oxygen Consumption; Performance; Phase; Physical Function; Pilot Projects; Population; Preparation; Production; Protein Biosynthesis; Proteins; Randomized Clinical Trials; Registries; Regulation; Sales; Skeletal Muscle; Testing; Tissues; Vascular blood supply; Vasodilation; Weight Gain; base; data management; design; dietary supplements; improved; insulin sensitivity; mortality; muscle form; muscle strength; protein degradation; public health relevance; research study; response; sarcopenia; sedentary; skeletal; sound; theories

 DESCRIPTION (provided by applicant): The long-term goal of this project is to develop and test a nutritional product that will improve physical function in individuals with heart failure (H) in the geriatric population. Our approach to nutritional therapy (NT) focuses on increasing skeletal muscle strength, improving vascular reactivity and optimizing regulation of energy substrate metabolism. All of these anticipated responses to NT should contribute to improved physical performance and thereby interrupt the vicious cycle of heart failure progression that ultimately leads to morbidity and mortality. While the popularity of nutritional supplements designed to address specific health concerns has grown, the credibility of the field has suffered due to an abundance of unsubstantiated claims and unscrupulous sales approaches. Essential Blends LLC is committed to marketing only products that have been developed from sound theory and validated by tightly controlled clinical trials. Thus, our ultimate goal is to perform a tightly controlled clinical trial assessing the response of individuals with HF to NT using our proprietary blend of amino acids. In order to perform such a study, a number of issues must be resolved. It is therefore the goal of this Phase I project to make all the necessary preparations t efficiently perform a controlled clinical trial in the subsequent Phase II aspect of this project. Following are the Specific Aims of this Phase I proposal: Specific Aim 1. To develop a palatable beverage that incorporates all of the essential components in the appropriate amounts in a format that can be produced relatively inexpensively. Specific Aim 2. To perform a pilot study to determine variability in determination of functional capacity in individuals with HF in order to determine the necessary number of subjects for the clinical trial, and to predict power reasonably accurately. Specific Aim 3. To prepare existing data management capabilities for the clinical trial and to expand the subject registry. The outcome of this Phase I project will be completion of all aspects of preparation to perform a clinical trial assessing the benefits of NT with our nutritional formulation.

 描述（由申请人提供）：该项目的长期目标是开发和测试一种营养产品，该产品将改善老年人群中心力衰竭（H）患者的身体功能。我们的营养治疗方法（NT）侧重于增加骨骼肌力量，改善血管反应性和优化能量底物代谢的调节。所有这些对NT的预期反应都应有助于改善体能，从而中断最终导致发病率和死亡率的心力衰竭进展的恶性循环。虽然旨在解决特定健康问题的营养补充剂越来越受欢迎，但由于大量未经证实的索赔和肆无忌惮的销售方法，该领域的信誉受到了影响。Essential Blends LLC致力于仅销售从合理理论开发并通过严格控制的临床试验验证的产品。因此，我们的最终目标是执行一个 严格控制的临床试验，使用我们专有的氨基酸混合物评估HF患者对NT的反应。为了进行这样的研究，必须解决一些问题。因此，本I期项目的目标是做好所有必要的准备，以便在本项目后续的II期方面有效地进行对照临床试验。以下是第一阶段提案的具体目标：具体目标1。为了开发一种可口的饮料，其以相对便宜的方式以适当的量掺入所有必需组分。具体目标2。进行一项初步研究，以确定HF个体功能能力测定的变异性，从而确定临床试验所需的受试者数量，并合理准确地预测把握度。具体目标3。准备临床试验的现有数据管理能力，并扩大受试者登记。这个第一阶段项目的结果将是完成所有方面的准备工作，以进行临床试验，评估NT与我们的营养配方的好处。