Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
研究概览
简要总结
Background:
The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. The study indicated that a tailored food concept increased nutritional intake in this patient group.
The objective of the current study is therefore to investigate these findings in a randomized clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of their energy and protein requirements.
Methods:
The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). 96 patients at nutritional risk, according to the NRS-2002 criteria, will be included in the study.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients at nutritional risk, according to the NRS-2002 system
- •patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)
- •well-functioning gastrointestinal tract
- •anticipated length of hospitalization of more than 3 days
排除标准
- •terminal patients
- •dysphagia
- •food allergy or intolerance
结局指标
主要结局
The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
时间窗: Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.
The patients energy requirement will be estimated both from the factorial method and by Harris and Benedicts formula. Protein requirement will be 18E% of the energy requirement. Recording of the dietary intake will be carried out on a daily basis over a periode of minimum 3 days and maxium 7 days
次要结局
- handgrip strength(at day 3, 5 and 7)
- average daily energy and protein intake(Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days)
- Use of tube feeding(The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.)
- use of parenteral nutrition(The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.)
- length of stay(an expected average of 9 days.)