Clinical trial NCT01240031: Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition
Nutritional Risk
Intake
Food sensory
Nutritional therapy
Energy
Protein
Handgrip strength
Reaction time
Quality of Life
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Arla Foods
name: The Danish Dairy Research Foundation, Denmark
First posted: 2010-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Intake
timeFrame: Study period during admission in hopsital
Secondary outcomes:
measure: Handgrip strength
timeFrame: Study period during admission in hopsital
measure: Reaction time
timeFrame: Study period during admission in hopsital
measure: Quality of life
timeFrame: 28 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: University of Copenhagen
name: Janice M Sorensen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorensen JM et al. P155 Food sensory issues in nutritional risk patients: an observational, interview-based study. Clin Nutr Suppl 2009;4(2):91.
citation: Sorensen JM et al. OP004 Food sensory issues in nutritional risk patients: a questionnaire study. Clin Nutr Suppl 2010;5(2):2.