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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by University of Copenhagen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240031
First Posted: November 15, 2010
Last Update Posted: November 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Arla Foods
The Danish Dairy Research Foundation, Denmark
Information provided by:
University of Copenhagen
  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 (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:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Handgrip strength [ Time Frame: Study period during admission in hopsital ]
    Grip track dynamometer (3 trials)

  • Reaction time [ Time Frame: Study period during admission in hopsital ]
    Test for Attentional Performance (TAP version 2, Psytest) Go/NoGo

  • Quality of life [ Time Frame: 28 days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 12, 2010
First Posted: November 15, 2010
Last Update Posted: November 15, 2010
Last Verified: November 2010

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


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