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Fortified Hospital Food as Nutritional Support (DHH)

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ClinicalTrials.gov Identifier: NCT01415635
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

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.


Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Nutritional intervention using Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : October 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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").



Primary Outcome Measures :
  1. 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. ]

    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 :
  1. handgrip strength [ Time Frame: at day 3, 5 and 7 ]
    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.

  2. 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 ]
  3. 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. ]
    Use of tube feeding will be registrated (yes or no and amount (ml.)

  4. 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. ]
    Registration of use of parenteral nutrition (yes or no). If yes how much (ml.).

  5. length of stay [ Time Frame: an expected average of 9 days. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01415635     History of Changes
Other Study ID Numbers: H-1-2011-048
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders