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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Arla Foods
The Danish Dairy Research Foundation, Denmark
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01240031
First received: November 12, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Malnutrition
 Other: Individualised nutritional therapy
Other: Usual nutrition care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Framework for Developing Appetising, Energy- and Protein-rich Foods for Patients at Nutritional Risk: Effect on Physiological Functions and Quality of Life

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Intake [ Time Frame: Study period during admission in hopsital ] [ Designated as safety issue: No ]
    Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)


Secondary Outcome Measures:
  • Handgrip strength [ Time Frame: Study period during admission in hopsital ] [ Designated as safety issue: No ]
    Grip track dynamometer (3 trials)

  • Reaction time [ Time Frame: Study period during admission in hopsital ] [ Designated as safety issue: No ]
    Test for Attentional Performance (TAP version 2, Psytest) Go/NoGo

  • Quality of life [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Short Form 36v2 Health Survey (SF36)
Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240031

Contacts
Contact: Janice M Sorensen, MSc (+45) 35 33 32 92 janice@life.ku.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Janice M Sorensen, MSc    (+45) 35 33 32 92    janice@life.ku.dk   
Sponsors and Collaborators
University of Copenhagen
Arla Foods
The Danish Dairy Research Foundation, Denmark
Investigators
Principal Investigator: Janice M Sorensen, MSc University of Copenhagen
  More Information

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.

Responsible Party: Janice Marie Sorensen, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01240031     History of Changes
Other Study ID Numbers: JMS-2010-29293/19069
Study First Received: November 12, 2010
Last Updated: November 12, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Malnutrition
Nutritional Risk
Intake
Food sensory
Nutritional therapy
 Energy
Protein
Handgrip strength
Reaction time
Quality of Life

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on March 01, 2015