Grant Title: Eicosapentaenoic Acid and Protein Modulation to Induce Anabolism in COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in net whole body protein balance
研究概览
简要总结
The aim of this study is the first aim of a NIH project that consists of 3 aims. The first aim examines the acute effects of two high-quality milk proteins (casein vs. whey) on whole-body and muscle protein metabolism in COPD patients with severe loss of muscle mass and the effects of adding leucine. The principal endpoints will be the extent of stimulation of net whole body protein synthesis as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism. After determining the optimal nutritional formulation based on the first aim we will continue to work on the second and third aim where fish oil supplementation will be part of the nutritional intervention as well.
详细描述
Cachectic COPD patients are characterized by a decreased muscle protein synthesis and an elevated myofibrillar protein breakdown. A substantial number of these patients, characterized by an enhanced systemic inflammatory response, fails to respond to nutritional therapy, which is of clinical relevance as weight gain to nutritional therapy is a significant, independent predictor of mortality in COPD.
In the present study, the acute protein anabolic effect of two high-quality milk protein supplements in COPD will be examined by comparing a hydrolyzed casein and whey protein meal. We make use of hydrolyzed proteins to correct for absorption differences. Furthermore the effects of these milk proteins with or without enrichment of leucine will be investigated.
Variables of interest are: net whole body protein synthesis; whole body protein synthesis and breakdown rate; whole body myofibrillar protein breakdown rate; whole body collagen breakdown; kinetics of insulin; glucose; amino acid levels.
It is the investigators hypothesis that a nutritional supplement containing casein protein and high levels of leucine will target the metabolic alterations of these cachectic COPD patients and will specifically stimulate protein anabolism. The knowledge gained from this study will benefit our insight in terms of promotion of protein anabolism in COPD patients. The long-term goal is to reformulate nutritional composition in accord with the effects of COPD on protein metabolism in order to ameliorate or even prevent progressive muscle wasting in these subjects, and improve their quality of life and survival rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of reference FEV1
- •Shortness of breath on exertion
- •Age 45 years and older
- •Clinically stable condition and not suffering from respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever) at least 4 weeks prior to the study
- •Cachexia based on the criteria: Body mass index ≤ 25 kg/m2 and/or FFM-Index: FFM/height2 ≤ 17 (males), 15 (females) kg/m2 and/or recent involuntary weight loss
排除标准
- •Established diagnosis of malignancy
- •Presence of fever within the last 3 days
- •Established diagnosis of Diabetes Mellitus
- •Untreated metabolic diseases including hepatic or renal disorder
- •Presence of acute illness or metabolically unstable chronic illness
- •Recent myocardial infarction (less than 1 year)
- •Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
- •Allergy to cow's milk protein
- •Any other condition according to the PI or study physicians would interfere with proper conduct of the study / safety of the patient
- •Failure to give informed consent
结局指标
主要结局
Change in net whole body protein balance
时间窗: 6 hours
Net whole body protein synthesis before and after protein feeding
次要结局
- Change in whole body protein synthesis rate(6 hours)
- Change in whole body protein breakdown rate(6 hours)
- Change in whole body collagen breakdown(6 hours)
- Change in insulin concentration(6 hours)
- Change in glucose concentration(6 hours)
- Change in plasma amino acid levels(6 hours)
- Change in whole body myofibrillar protein breakdown rate(6 hours)
研究者
Marielle PKJ Engelen, PhD
PhD
Texas A&M University