Fortified Hospital Food as Nutritional Support (DHH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01415635
First received: July 19, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Malnutrition
Dietary Supplement: Nutritional intervention using

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements. [ Time Frame: 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. ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • handgrip strength [ Time Frame: at day 3, 5 and 7 ] [ Designated as safety issue: No ]
    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.

  • average daily energy and protein intake [ Time Frame: Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days ] [ Designated as safety issue: No ]
  • Use of tube feeding [ Time Frame: The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days. ] [ Designated as safety issue: No ]
    Use of tube feeding will be registrated (yes or no and amount (ml.)

  • use of parenteral nutrition [ Time Frame: The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days. ] [ Designated as safety issue: No ]
    Registration of use of parenteral nutrition (yes or no). If yes how much (ml.).

  • length of stay [ Time Frame: an expected average of 9 days. ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional intervention
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
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").

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415635

Locations
Denmark
Herlev University Hospital
Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Study Director: Tina Munk, MSc. Herlev University Hospital, Denmark
  More Information

Publications:
Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01415635     History of Changes
Other Study ID Numbers: H-1-2011-048
Study First Received: July 19, 2011
Last Updated: December 12, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
Nutritional risk, Hospital food, Nutritional Intervention

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on April 17, 2014