Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT01415635
Status:
COMPLETED
Last Update Posted:
2012-12-13
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fortified Hospital Food as Nutritional Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-12', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2012-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.', 'timeFrame': '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.', 'description': '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.\n\nRecording of the dietary intake will be carried out on a daily basis over a periode of minimum 3 days and maxium 7 days'}], 'secondaryOutcomes': [{'measure': 'handgrip strength', 'timeFrame': 'at day 3, 5 and 7', 'description': '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.'}, {'measure': 'average daily energy and protein intake', 'timeFrame': 'Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days'}, {'measure': 'Use of tube feeding', 'timeFrame': 'The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.', 'description': 'Use of tube feeding will be registrated (yes or no and amount (ml.)'}, {'measure': 'use of parenteral nutrition', 'timeFrame': 'The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.', 'description': 'Registration of use of parenteral nutrition (yes or no). If yes how much (ml.).'}, {'measure': 'length of stay', 'timeFrame': 'an expected average of 9 days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nutritional risk, Hospital food, Nutritional Intervention'], 'conditions': ['Malnutrition']}, 'referencesModule': {'references': [{'pmid': '18621450', 'type': 'BACKGROUND', 'citation': "Hansen MF, Nielsen MA, Biltz C, Seidelin W, Almdal T. Catering in a large hospital--does serving from a buffet system meet the patients' needs? Clin Nutr. 2008 Aug;27(4):666-9. doi: 10.1016/j.clnu.2008.05.004. Epub 2008 Jul 14."}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe 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.\n\nThe 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.\n\nMethods:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients at nutritional risk, according to the NRS-2002 system\n* patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)\n* well-functioning gastrointestinal tract\n* anticipated length of hospitalization of more than 3 days\n\nExclusion Criteria:\n\n* terminal patients\n* dysphagia\n* food allergy or intolerance'}, 'identificationModule': {'nctId': 'NCT01415635', 'acronym': 'DHH', 'briefTitle': 'Fortified Hospital Food as Nutritional Support', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'H-1-2011-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional intervention', 'description': '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).', 'interventionNames': ['Dietary Supplement: Nutritional intervention using']}], 'interventions': [{'name': 'Nutritional intervention using', 'type': 'DIETARY_SUPPLEMENT', 'description': '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").', 'armGroupLabels': ['Nutritional intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev University Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Tina Munk, MSc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Herlev University Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}