- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01415635
Fortified Hospital Food as Nutritional Support (DHH)
Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Copenhagen
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Herlev, Copenhagen, Danimarca, 2730
- Herlev University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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).
|
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").
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
Lasso di tempo: 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.
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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.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
handgrip strength
Lasso di tempo: 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.
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at day 3, 5 and 7
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average daily energy and protein intake
Lasso di tempo: Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
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Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
|
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Use of tube feeding
Lasso di tempo: The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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Use of tube feeding will be registrated (yes or no and amount (ml.)
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The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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use of parenteral nutrition
Lasso di tempo: The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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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.
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length of stay
Lasso di tempo: an expected average of 9 days.
|
an expected average of 9 days.
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Tina Munk, MSc., Herlev University Hospital, Denmark
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- H-1-2011-048
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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