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

November 12, 2010 updated by: University of Copenhagen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Janice M Sorensen, MSc
  • Phone Number: (+45) 35 33 32 92
  • Email: janice@life.ku.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

The Danish Dairy Research Foundation, Denmark
Arla Foods

Investigators

  • Principal Investigator: Janice M Sorensen, MSc, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Sorensen JM et al. P155 Food sensory issues in nutritional risk patients: an observational, interview-based study. Clin Nutr Suppl 2009;4(2):91.
  • Sorensen JM et al. OP004 Food sensory issues in nutritional risk patients: a questionnaire study. Clin Nutr Suppl 2010;5(2):2.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (ESTIMATE)

November 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 12, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMS-2010-29293/19069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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