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Fortified Hospital Food as Nutritional Support (DHH)

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nutritional intervention using
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Nutritional risk, Hospital food, Nutritional Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutritional intervention

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
average daily energy and protein intake
Use of tube feeding
Use of tube feeding will be registrated (yes or no and amount (ml.)
use of parenteral nutrition
Registration of use of parenteral nutrition (yes or no). If yes how much (ml.).
length of stay

Full Information

First Posted
July 19, 2011
Last Updated
December 12, 2012
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT01415635
Brief Title
Fortified Hospital Food as Nutritional Support
Acronym
DHH
Official Title
Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Nutritional risk, Hospital food, Nutritional Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional intervention
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional intervention using
Intervention Description
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").
Primary Outcome Measure Information:
Title
The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
Description
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
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.
Secondary Outcome Measure Information:
Title
handgrip strength
Description
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.
Time Frame
at day 3, 5 and 7
Title
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
Title
Use of tube feeding
Description
Use of tube feeding will be registrated (yes or no and amount (ml.)
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.
Title
use of parenteral nutrition
Description
Registration of use of parenteral nutrition (yes or no). If yes how much (ml.).
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.
Title
length of stay
Time Frame
an expected average of 9 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Munk, MSc.
Organizational Affiliation
Herlev University Hospital, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Herlev University Hospital
City
Herlev
State/Province
Copenhagen
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
18621450
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.
Results Reference
background

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Fortified Hospital Food as Nutritional Support

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