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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01240031
• Other study ID #: JMS-2010-29293/19069
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2010
• Last updated: November 12, 2010
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: November 2010
• Source: University of Copenhagen
• Contact: Janice M Sorensen, MSc
• Phone: (+45) 35 33 32 92
• Email: janice[@]life.ku.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.
• Usual nutrition care
Nutritional therapy according to current practice and general nutrition advice.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Arla Foods, The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Sorensen JM et al. OP004 Food sensory issues in nutritional risk patients: a questionnaire study. Clin Nutr Suppl 2010;5(2):2.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake	Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)	Study period during admission in hopsital	No
Secondary	Handgrip strength	Grip track dynamometer (3 trials)	Study period during admission in hopsital	No
Secondary	Reaction time	Test for Attentional Performance (TAP version 2, Psytest) Go/NoGo	Study period during admission in hopsital	No
Secondary	Quality of life	Short Form 36v2 Health Survey (SF36)	28 days	No