Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Acute change in Net whole body protein synthesis rate
研究概览
简要总结
Weight loss commonly occurs in lung cancer patients, negatively influencing their quality of life, treatment response and survival. Gains in lean body mass are difficult to achieve in cancer unless specific metabolic abnormalities are targeted. It is our hypothesis that a nutritional supplement containing a high amount of essential amino acids will target the metabolic alterations of cancer patients. Preliminary research performed in our laboratory in elderly supports this hypothesis. We hypothesize that intake of an essential amino acid nutritional supplement will positively influence protein synthesis rate in advanced non-small cell lung cancer (NSCLC) patients. Furthermore, insight in the underlying mechanism of the higher anabolic response of the essential amino acid supplement will be examined. This information will potentially enable us to formulate a supplement that is more effective than normal food intake, and that will reduce the need for muscle protein breakdown.
详细描述
In this study, we will test the following hypothesis: A high-leucine essential amino acid mixture stimulates whole body protein synthesis (and in this way protein anabolism) to a larger extent than a regular balanced mixture of total (essential and non-essential) amino acids in NSCLC patients with and without recent weight loss. The principal endpoint will be the extent of stimulation of protein synthesis rate as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism. This project will provide important clinical information, based on novel fundamental basic knowledge on the process and the specific underlying mechanisms of muscle wasting in patients with NSCLC, and the role of EAA as a potential anabolic substrate. In this way, it will provide preliminary data for the development of nutritional strategies that will prevent or even stop this process of ongoing muscle loss in NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recently diagnosed with Stage III (unresectable) or Stage IV lung cancer (only for the NSCLC group)
- •Ability to sign informed consent
- •Age 40 years and older
排除标准
- •Previous anti-cancer therapy (e.g. radiotherapy, chemotherapy) or surgery less than 4 weeks prior to the experiment.
- •Presence of fever within the last 3 days
- •Established diagnosis of Diabetes Mellitus
- •BMI > 35 kg/m2
- •Untreated metabolic diseases including hepatic or renal disorder
- •Presence of acute illness or metabolically unstable chronic illness
- •Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
- •Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of referen¬ce FEV1 (only for the healthy control group)
- •Use of supplements enriched with amino acids
- •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
研究组 & 干预措施
Total AA vs EAA+LEU
干预措施: Total AA vs EAA+LEU (Dietary Supplement)
EAA+LEU vs total AA
干预措施: EAA+LEU vs total AA (Dietary Supplement)
结局指标
主要结局
Acute change in Net whole body protein synthesis rate
时间窗: Up to 2 years
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
次要结局
- Acute change in Urea turnover rate(Up to 2 years)
- Acute change in Liver protein synthesis rate(Up to 2 years)
- Acute change in plasma Amino acid concentrations(Up to 2 years)
- Acute change in Whole body collagen breakdown rate(Up to 2 years)
- Acute change in Arginine turnover rate(Up to 2 years)
- Acute change in plasma Insulin concentrations(Up to 2 years)
- Acute change in Whole body myofibrillar protein breakdown rate(Up to 2 years)
- Acute change in plasma Glucose concentrations(Up to 2 years)
研究者
Marielle PKJ Engelen, PhD
PhD
Texas A&M University