Fortified Hospital Food as Nutritional Support (DHH)
|ClinicalTrials.gov Identifier: NCT01415635|
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : December 13, 2012
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.
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|
|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|
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").
- 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
- 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.
- 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 ]
- 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.)
- 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.).
- length of stay [ Time Frame: an expected average of 9 days. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415635
|Herlev University Hospital|
|Herlev, Copenhagen, Denmark, 2730|
|Study Director:||Tina Munk, MSc.||Herlev University Hospital, Denmark|