Fortified Hospital Food as Nutritional Support

Malnutrition Clinical Trial

— DHH  

Official title:

Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415635
• Other study ID #: H-1-2011-048
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: December 12, 2012
• Start date: October 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2012
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Nutritional intervention using
The study is af 12 week randomized clinical trail with inclusion of 96 patients at nutritional risk, according to the NRS-2002 system. The intervention group is is given a tailored nutritional care(the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital").

Locations

Country	Name	City	State
Denmark	Herlev University Hospital	Herlev	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.	The patients energy requirement will be estimated both from the factorial method and by Harris and Benedicts formula. Protein requirement will be 18E% of the energy requirement.; Recording of the dietary intake will be carried out on a daily basis over a periode of minimum 3 days and maxium 7 days	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.	No
Secondary	handgrip strength	Handgrip strength (HGS)will be measured with a Jamar Digital Hand Dynanometer. HGS will only be measured in the right hand because the right hand i significantly stronger in right-handed subjects and there is no significant difference between the two sides in left-handed subjects. Subjects will be encouraged to perform maximal contractions three times with a 15-s interval and the average value will be recorded.	at day 3, 5 and 7	No
Secondary	average daily energy and protein intake		Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days	No
Secondary	Use of tube feeding	Use of tube feeding will be registrated (yes or no and amount (ml.)	The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.	No
Secondary	use of parenteral nutrition	Registration of use of parenteral nutrition (yes or no). If yes how much (ml.).	The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.	No
Secondary	length of stay		an expected average of 9 days.	No