Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Protein balance
研究概览
简要总结
A prospective, randomized and controlled study is proposed to establish whether an enteral nutrition support regimen based on pressurized whey protein and glucose improves the postoperative utilization of amino acid substrates compared to a drink based on glucose alone. The kinetics of protein metabolism (protein breakdown, protein synthesis and amino acid oxidation) will be investigated using stable isotope methodology before and after surgery in patients undergoing colon resection. Stable isotope infusions will be conducted one week before surgery and on the second postoperative day for two hours in the fasted state and for four hours while sipping the enteral nutrition support regimen. Patients will consume one of two enteral nutrition support regimens consisting of a drink containing either pressurized whey protein and glucose or glucose alone. It is hypothesized that an enteral nutrition support regimen based on pressurized whey protein and glucose promotes positive protein balance through increased protein synthesis or reduced protein breakdown compared to glucose alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age older than 18 years
- •ASA class I to III
- •colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total and hemicolectomy and low anterior resection)
- •body mass index >17 and <30 kg.m-2
- •stable weight over the preceding three months (<10 % body weight loss)
- •serum albumin >35 g/L
排除标准
- •severe cardiac, renal or hepatic failure
- •hyper and hypothyroidism
- •active inflammatory bowel or diverticular disease
- •musculoskeletal or neuromuscular disease
- •anemia (hematocrit <30)
- •albumin < 25 g/l
- •pregnancy
- •use of steroids.
结局指标
主要结局
Protein balance
时间窗: Assessed for 6 hours one time before surgery and once again on the second post-op day
Protein balance is assessed using the stable isotope tracer C-13 leucine. Protein breakdown, protein synthesis and amino acid oxidation are measured through blood and expired air samples.
次要结局
未报告次要终点
