Casein Protein and Leucine Supplementation to Induce Anabolism in COPD Patients and Healthy Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Net whole-body protein synthesis with different levels of protein intake (Fifth Study Day)
研究概览
简要总结
Weight loss commonly occurs in patients with COPD, negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of this weight loss and independently increases mortality. This study will provide relevant clinical information in regards to the anabolic properties of specific dietary substrates and their co-active anabolic effects. Hypotheses: 1) That supplementation of a hydrolyzed casein-based protein meal with the addition of carbohydrates is more anabolic than a hydrolyzed casein-based protein meal without carbohydrates in COPD patients and healthy older adults; 2) That leucine addition to a hydrolyzed casein-based protein meal only enhances the protein anabolic response in COPD patients and healthy older adults when carbohydrates are not added to the protein meal; 3) That COPD patients have a more efficient protein anabolic response to a hydrolyzed casein-based protein meal than healthy older adults.
A fifth study day was added to measure protein requirements of included individuals to be able to interpret their response to the other interventions on the other study days, and to test the hypothesis that subjects with lower protein requirements respond less to intervention with leucine and/or carbohydrates. For the 5th additional test day we will first approach the 10 COPD and 10 healthy subjects who already completed the first 4 study days (and signed the re-contact form) to come back for this extra test day. We will (pre-)screen these subjects by phone for eligibility and check for changes in their recent medical history (with help of the (pre-)screening questionnaires in CRF). If all inclusion criteria are still met, these subjects will be asked to provide a written re-consent. If necessary, we will recruit new subjects who will complete only one of the four test days (i.e. the test day on which the hydrolyzed casein-based protein meal with carbohydrates is provided) and the additional 5th study day.
详细描述
The study involves 5 study days. The duration of the first 4 study days is approximately 6.5 hours per day and the duration of the 5th study day is approximately 8 hours. On each of the first 4 study days the effect a casein protein meal with or without leucine and carbohydrates will be examined. On the fifth study day the effect of 4 different levels of casein protein and carbohydrate intake by sip feeding (every 20 minutes) is examined.
Also, subjects will receive a mixture of amino acids (little parts of protein) which are a little bit heavier than normal, called stable isotopes. This is the so-called stable isotope method to investigate protein behavior in the body (protein kinetics). Altogether about 75 ml of blood will be drawn per study day to assess outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 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
- 未提供
结局指标
主要结局
Net whole-body protein synthesis with different levels of protein intake (Fifth Study Day)
时间窗: before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min)
Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown) with 4 different levels of protein intake (duration of each level: 2 hours) as sip feeding (every 20 minutes)
Net whole-body protein synthesis
时间窗: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal
Change in net whole-body protein synthesis (whole-body protein synthesis - whole-body protein breakdown)
次要结局
- Splanchnic extraction(0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal)
- Body composition(1 day)
- Whole-body protein synthesis(0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal)
- Inflammatory mediators(90 min before protein meal)
- Whole-body protein breakdown(0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal)
- Whole-body protein synthesis with different levels of protein intake (Fifth Study Day)(before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min))
- Whole-body protein breakdown with different levels of protein intake (Fifth Study Day)(before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min))
- Glucose(0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal)
- Amino acid concentrations(0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal)
- Hormones with different levels of protein intake (Fifth Study Day)(before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min))
- Glucose with different levels of protein intake (Fifth Study Day)(before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min))
- Amino acid concentrations with different levels of protein intake (Fifth Study Day)(before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min))
- Skeletal and respiratory muscle strength(1 day)
- Hormones(0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min post-protein meal)
- Splanchnic extraction with different levels of protein intake (Fifth Study Day)(before each sip feeding in the second hour of a level of protein intake ( at 120, 140 and 160 min))
研究者
Marielle PKJ Engelen, PhD
PhD
Texas A&M University