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Fortified Hospital Food as Nutritional Support

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01415635
Acronym
DHH
Enrollment
84
Registered
2011-08-12
Start date
2011-10-31
Completion date
2012-02-29
Last updated
2012-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Nutritional risk, Hospital food, Nutritional Intervention

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.

Interventions

DIETARY_SUPPLEMENTNutritional 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).

Sponsors

Copenhagen University Hospital at Herlev
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.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

MeasureTime frameDescription
handgrip strengthat day 3, 5 and 7Handgrip 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 intakePatient 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 feedingThe 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 nutritionThe 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 stayan expected average of 9 days.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026