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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01240031
Enrollment
80
Registered
2010-11-15
Start date
2010-04-30
Completion date
2010-12-31
Last updated
2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Malnutrition, Nutritional Risk, Intake, Food sensory, Nutritional therapy, Energy, Protein, Handgrip strength, Reaction time, Quality of Life

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.

Interventions

OTHERIndividualised 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.

Nutritional therapy according to current practice and general nutrition advice.

Sponsors

Arla Foods
CollaboratorINDUSTRY
The Danish Dairy Research Foundation, Denmark
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
IntakeStudy period during admission in hopsitalExpressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)

Secondary

MeasureTime frameDescription
Handgrip strengthStudy period during admission in hopsitalGrip track dynamometer (3 trials)
Reaction timeStudy period during admission in hopsitalTest for Attentional Performance (TAP version 2, Psytest) Go/NoGo
Quality of life28 daysShort Form 36v2 Health Survey (SF36)

Countries

Denmark

Contacts

Primary ContactJanice M Sorensen, MSc
janice@life.ku.dk(+45) 35 33 32 92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026