Clinical trial NCT01415635: Fortified Hospital Food as Nutritional Support
Official title: Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Nutritional risk, Hospital food, Nutritional Intervention
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 84
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: Background:

The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. The study indicated that a tailored food concept increased nutritional intake in this patient group.

The objective of the current study is therefore to investigate these findings in a randomized clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of their energy and protein requirements.

Methods:

The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). 96 patients at nutritional risk, according to the NRS-2002 criteria, will be included in the study.


Eligibility criteria: Inclusion Criteria:

* patients at nutritional risk, according to the NRS-2002 system
* patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)
* well-functioning gastrointestinal tract
* anticipated length of hospitalization of more than 3 days

Exclusion Criteria:

* terminal patients
* dysphagia
* food allergy or intolerance

Primary outcomes:
measure: The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
timeFrame: Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.
Secondary outcomes:
measure: handgrip strength
timeFrame: at day 3, 5 and 7
measure: average daily energy and protein intake
timeFrame: Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
measure: Use of tube feeding
timeFrame: The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
measure: use of parenteral nutrition
timeFrame: The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.
measure: length of stay
timeFrame: an expected average of 9 days.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hospital
state: Copenhagen
Study officials:
affiliation: Herlev University Hospital, Denmark
name: Tina Munk, MSc.
role: STUDY_DIRECTOR
References:
citation: Hansen MF, Nielsen MA, Biltz C, Seidelin W, Almdal T. Catering in a large hospital--does serving from a buffet system meet the patients' needs? Clin Nutr. 2008 Aug;27(4):666-9. doi: 10.1016/j.clnu.2008.05.004. Epub 2008 Jul 14.