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

Not Applicable

• Conditions: Malnutrition

• Registration Number: NCT01240031
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2010-04
• Status Verified: 2010-11
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Last Update Submitted: 2010-11-12
• Study First Posted: 2010-11-15
• Last Update Posted: 2010-11-15
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intake	Study period during admission in hopsital	Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark