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临床试验/NCT01240031
NCT01240031Unknown不适用

Framework for Developing Appetising, Energy- and Protein-rich Foods for Patients at Nutritional Risk: Effect on Physiological Functions and Quality of Life

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Intake

研究概览

简要总结

The purpose of this study is to determine whether individualised nutritional therapy comprised of appetising, energy- and protein-rich foods can have a positive effect on physiological function and quality of life of undernourished patients as compared to usual nutrition care.

详细描述

Undernutrition and insufficent dietary intake in hospitalised patients is a widespread problem. It is associated with increased morbidity and mortality, worsened physiological function and quality of life and increased expenses for the health care system. Food quality has been shown to be positively associated with dietary intake in patients. However, there has lacked knowledge on how food quality can be optimised to promote intake. A project was therefore initiated, which aimed at establishing a framework for developing appetising, energy- and protein-rich foods for patients at nutritional risk. This project included qualitative and quantitative investigation of nutritional risk patients' meal experiences and preferences (se citations below). These results have served as a basis for optimsing energy- and protein-rich foods as part of an indivudalised nutritional therapy aimed at improving dietary intake in nutritional risk patients.

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

入选标准

  • Nutritional risk as per Nutrition Risk Screening 2002 (NRS-2002)
  • Hospital admited at Rigshospitalets (various medical departments)
  • Expect length of stay >= 5 days
  • Informed consent to participate

排除标准

  • Dementia or other psychiatric condition resulting in an inability to give informed consent and to understand study materials.
  • Inability to fairly perform the functional measurements (i.e., handgrip strength, reaction time) due to a hand, wrist, arm, shoulder injury or condition.
  • Enteral or parenteral nutrition as primary nutritional therapy.
  • Previous participation in the study.

结局指标

主要结局

Intake

时间窗: Study period during admission in hopsital

Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)

次要结局

  • Handgrip strength(Study period during admission in hopsital)
  • Reaction time(Study period during admission in hopsital)
  • Quality of life(28 days)

研究者

申办方类型
Other

研究点 (2)

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