Fortified Hospital Food as Nutritional Support

Study Overview
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Brief Summary
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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.

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

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Nutritional intervention using


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional intervention<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Use of tube feeding will be registrated (yes or no and amount (ml.) | 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 | Registration of use of parenteral nutrition (yes or no). If yes how much (ml.). | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional risk, Hospital food, Nutritional Intervention