Fortified Hospital Food as Nutritional Support

NCT01415635 | Completed DMC

• 1 other identifier: H-1-2011-048
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Nutritional risk, Hospital food, Nutritional Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• handgrip strength

  at day 3, 5 and 7

• 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

• Use of tube feeding

  The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.

• use of parenteral nutrition

  The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.

• length of stay

  an expected average of 9 days.

Study Arms (1)

Nutritional intervention

EXPERIMENTAL

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")(intervention group).

Dietary Supplement: Nutritional intervention using

Interventions

Nutritional intervention using DIETARY_SUPPLEMENT

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").

Nutritional intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• terminal patients
• dysphagia
• food allergy or intolerance

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Herlev University Hospital

Herlev, Copenhagen, 2730, Denmark

Location

Related 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.

  PMID: 18621450 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Tina Munk, MSc.

  Herlev University Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: August 12, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

DK (1)