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临床试验/NCT01276795
NCT01276795已完成不适用

Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2010年1月1日最近更新:
适应症

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

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

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other

研究点 (2)

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