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

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University of Copenhagen

Status

Unknown

Conditions

Malnutrition

Treatments

Other: Individualised nutritional therapy
Other: Usual nutrition care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01240031
JMS-2010-29293/19069

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Janice M Sorensen, MSc

Data sourced from clinicaltrials.gov

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