A Randomized, Controlled Clinical Trial on the Effect of Protein Supplement on Lean Body Mass in Patients With Community Acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Loss of Lean Body Mass
研究概览
简要总结
The purpose of this clinical trial is to reduce the patient's loss of lean body mass by protein supplementation during hospitalization and 60 days after hospital discharge. Also, the study aims to reduce the risk of readmission to the hospital due to relapse or complications and thereby improving the overall health for the patients.
The intervention group will receive protein supplementation during hospitalization and after discharge, while the control group will continue their normal diet.
详细描述
Infections are globally the biggest cause of mortality. In Denmark community acquired pneumonia is one of the most common causes for infections in patients. Mortality in pneumonia has been stable high over the past 10 years. Therefore, it is relevant to look at improving the prognosis of these patients. After a longer period of hospitalization, patients generally have a poor condition with loss of body weight and lean body mass. Hereafter, patients must often undergo a longterm rehabilitation period and they become inactive and fatigue.
This is a threat for the patients, due to the fact that there is a higher risk of complications and readmissions.
Proteins are the body's building blocks. Thus, supplementing patients with a daily higher protein content, it is believed to reduce their loss of lean body mass, and thereby reduce the total loss of body weight as well. Protein supplementation together with vitamin- and mineral supplementation is thought to improve all these health risk markers for the patients.
Methods:
Inclusion: 40 men and women >60 years hospitalized with community acquired pneumonia Intervention: The patients will be randomized to either the control- or intervention group. They will receive the same treatment and care, the only difference is that the patients in the intervention group will receive protein- and vitamin supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with community acquired pneumonia
- •>60 years
- •Patients who are able to speak and understand Danish
排除标准
- •Patients with hospitalized acquired pneumonia
- •Patients with septic shock
- •Patients with an active cancer and in cancer treatment
- •Patients in dialysis
- •ICU patients
- •Patients unable or unwilling to give informed consent
结局指标
主要结局
Loss of Lean Body Mass
时间窗: Change from Baseline lean body mass until 2 months after discharged
Loss of lean body mass measured by bioimpedance
次要结局
- Loss of Body weight(Change from Baseline weight until 2 months after discharged)
- Readmissions(Up to 6 months)
- Normal daily living function(Change in physical condition from Baseline until 2 months after discharged)
- Quality of life measured by units on a scale(Change in individual experiences regards to quality of life from Baseline until 2 months after discharged)
- Length of hospital stay between the two groups(From admission until discharge (an average of 5 days))