Metabolic and Functional Changes in Relation to Nutritional Status in Chronic Heart Failure and Chronic Obstructive Pulmonary Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Net whole-body protein synthesis
研究概览
简要总结
Weight loss commonly occurs in patients with chronic heart failure (CHF) and chronic obstructive pulmonary disorder (COPD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CHF and COPD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. The purpose of this cross-sectional study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CHF and COPD patients compared to matched healthy controls. This will provide required information that is necessary to implement new strategies to develop optimal nutritional regimen in CHF and COPD. The hypothesis is that CHF and COPD are related to decreased gut function and absorption, leading to decreased anabolic response. Second, this decreased nutritional status is linked to reduced muscle functioning and possibly decreased cognition. In addition, we will examine the effect of aging on by comparing gut function digestion and absorption of the CHF and COPD aged matched healthy controls to a group of young healthy subjects.
详细描述
This study involves one test day of approximately 7-8 hours. On this test day subjects will ingest a sugar drink to assess gut permeability and gut function, and a protein meal to measure digestion/absorption and the anabolic response to food intake. Subjects will also receive a mixture of amino acids that are made a little heavier than normal, called stable isotopes. This stable isotopes is used to investigate protein behavior in the body (protein kinetics). Blood (100-120 ml in total) and urine samples will be collected over 7 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
- •History of untreated metabolic diseases including hepatic or renal disorder
- •Presence of acute illness or metabolically unstable chronic illness
- •Presence of fever within the last 3 days
- •Body mass index >40 kg/m2 (healthy subjects only)
- •Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
- •Use of protein or amino acid containing nutritional supplements within 5 days of first study day
- •Current use of long-term oral corticosteroids (CHF only)
- •Use of short course of oral corticosteroids within 4 weeks preceding first study day
- •Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •(Possible) pregnancy
结局指标
主要结局
Net whole-body protein synthesis
时间窗: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
change in whole-body protein synthesis rate after intake of meal
次要结局
- Whole body collagen breakdown rate(Postabsorptive state during 3 hours)
- Myofibrillar protein breakdown rate(0,15,30,45,60,75,90,105,120,150,180,210 min post-meal)
- Insulin response to feeding(during 3 hours after feeding)
- Glucose absorption(7 hours)
- Fat-free mass(postabsorptive state during 15 min)
- Skeletal and respiratory muscle strength(1 day)
- Arginine turnover rate(postabsorptive state during 3 hours)
- Taurine turnover rate(postabsorptive state during 3 hours)
- Citrulline Rate of appearance(Postabsorptive state during 2 hours)
- Gut permeability(7 hours)
- Fatty acid digestion after feeding(0,15,30,45,60,75,90,105,120,150,180,210 min post-meal)
- Tryptophan turnover rate(Postabsorptive state during 3 hours)
- Cognitive function(1 day)
- Protein digestion after feeding(0,15,30,45,60,75,90,105,120,150,180,210, min post-meal)
- Glycine rate of appearance(Postabsorptive state during 3 hours)
研究者
Marielle PKJ Engelen, PhD
PhD
Texas A&M University