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NCT Number: NCT01415635

Fortified Hospital Food as Nutritional Support

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev University Hospital

Herlev, Copenhagen, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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").

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Official study title

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

Acronym: DHH

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 12, 2011
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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