Nutritional Intervention in Malnourished Elderly Patients
Effectiveness of Nutritional Intervention in Malnourished Elderly Patients
研究概览
详细说明
Malnutrition is still a problem in elderly patients and this may be associated with reduced muscle strength and ADL function (activities of daily living). Malnourished Medical Inpatients/Outpatients and District Nurse patients with a Body Mass Index < 20 kg/m2 are asked to participate.
Comparison(s): The patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements. The study supplementation is Fresubin Protein Energy Drink and this will give additional 600 kcal and 40 gram protein a day. The study period is 12 weeks with a visit at inclusion, week 6 and week 12.
Primary and secondary outcome parameters are measured at inclusion and week 12
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Tromsoe、挪威、9038
- University Hospital of Northern Norway, Dep of Medical Gastroenterology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Body Mass Index < 20 kg/m2
- Medical In/Outpatient or District Nurse-patient
- Able to take nutritional supplement (sip feeding)
- Able to walk
- Written patient informed consent
Exclusion Criteria:
- Actual malignancy
- Dementia with a Mini Mental Status score < 24
- Severe depression
- Need for Total Parenteral Nutrition or Tube Feeding
- Prescribed nutritional supplements during more than the last week
- Life expectancy of less than 6 months
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Nutritional supplement
2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein
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Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)
其他名称：
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有源比较器：Dietary advice
ordinary dietary advice with a recommendation of four meals per day or similar dietary advice
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The patients will receive ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and no daily sip feeding supplements.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Functional Health (Short form 36)
大体时间：Start and 12 weeks
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Start and 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Nutritional Measures (at inclusion and week 12)
大体时间：Start and 12 weeks
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Start and 12 weeks
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Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)
大体时间：at 6 and 12 weeks
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at 6 and 12 weeks
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Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale
大体时间：Start and 12 weeks
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Start and 12 weeks
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Observed ADL
大体时间：Start and at 12 weeks
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Barthels index
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Start and at 12 weeks
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Timed Up and Go test
大体时间：Start and12 weeks
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Start and12 weeks
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Hand grip strength
大体时间：Start and 12 weeks
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Start and 12 weeks
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合作者和调查者
调查人员
- 学习椅：Jon R Florholmen, MD, PhD、University Hospital of Northern Norway, Dep of Medical Gastroenterology
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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