Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Other: Individualised nutritional therapy
* Other: Usual nutrition care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Individualised nutritional therapy|Nutritional therapy as based on previous results of the project on patient meal experiences and preferences (note citations below) and comprising of: Thorough sensory and nutrition assessment (questionnaire). Nutrition plan adjusted daily according to the assessment. Serving appetising, energy- and protein-dense meals, snacks and drinks.|
|Other: Usual nutrition care|Nutritional therapy according to current practice and general nutrition advice.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intake | Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording) | Study period during admission in hopsital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength | Grip track dynamometer (3 trials) | Study period during admission in hopsital | 
| Reaction time | Test for Attentional Performance (TAP version 2, Psytest) Go/NoGo | Study period during admission in hopsital | 
| Quality of life | Short Form 36v2 Health Survey (SF36) | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition, Nutritional Risk, Intake, Food sensory, Nutritional therapy, Energy, Protein, Handgrip strength, Reaction time, Quality of Life