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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Malnutrition	Other: Individualised nutritional therapy; Other: Usual nutrition care	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
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
Study Start Date :	April 2010
Estimated Primary Completion Date :	December 2010
Estimated Study Completion Date :	December 2010

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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