Effectiveness of Nutritional Intervention in Malnourished Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Functional Health (Short form 36)
研究概览
简要总结
The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.
详细描述
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nutritional supplement
2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein
干预措施: Sip feeding (Dietary Supplement)
Dietary advice
ordinary dietary advice with a recommendation of four meals per day or similar dietary advice
干预措施: Dietary Advice (Dietary Supplement)
结局指标
主要结局
Functional Health (Short form 36)
时间窗: Start and 12 weeks
次要结局
- Nutritional Measures (at inclusion and week 12)(Start and 12 weeks)
- Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)(at 6 and 12 weeks)
- Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale(Start and 12 weeks)
- Observed ADL(Start and at 12 weeks)
- Timed Up and Go test(Start and12 weeks)
- Hand grip strength(Start and 12 weeks)