Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-03-29 @ 9:31 AM
Study NCT ID:
NCT06399250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Channel Food Concept: the Effect Meal Service on Food Intake During Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D011502', 'term': 'Protein-Energy Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011488', 'term': 'Protein Deficiency'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total protein intake', 'timeFrame': 'during hospitalization (minimal 2days max 5days)', 'description': 'total protein intake (g/kg/d)'}], 'secondaryOutcomes': [{'measure': 'total energy intake', 'timeFrame': 'during hospitalization (minimal 2days max 5days)', 'description': 'energy intake in kcal per day'}, {'measure': 'macronutrient intake', 'timeFrame': 'during hospitalization (minimal 2days max 5days)', 'description': 'carbohydrate, fat and protein intake (g/day)'}, {'measure': 'Patient appreciation', 'timeFrame': 'during hospitalization (minimal 2days max 5days)', 'description': 'Patient appreciation will be assessed using a question "what grade would you give the hospital food'}, {'measure': 'Body weight upon hospital admission', 'timeFrame': 'upon hospital admission', 'description': 'body weight in kilograms'}, {'measure': 'Body height upon hospital admission', 'timeFrame': 'upon hospital admission', 'description': 'body height in meters'}, {'measure': 'reason hospital admission', 'timeFrame': 'upon hospital admission', 'description': 'will be derived from electronical patient dossier'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition Poor', 'Protein-Energy Malnutrition']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess food intake in hospitalized patients.\n\nThe present study will evaluate the impact of a novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation\n\nFood intake will be assessed (as part of usual care) by weighing all leftovers (e.g. food that patients did not consume).', 'detailedDescription': "There are various possible strategies to increase protein intake during hospitalization, such as providing more protein-rich foods, fortifying meals and/or food products, supplementation with oral nutritional supplements (ONS), and/or providing well-timed snacks. An appropriate in-hospital meal service is regarded as a key element of the strategy to minimize deterioration of the nutritional status. Conventional hospital meals, 3 main meals a day prepared by a central kitchen, are often low in protein and energy and are not appreciated by patients due to lack of taste, colour and flavour, resulting in inadequate food intake particularly protein intake. There are a number of avenues to improve nutritional intake, with type of meal service and existence of individual contact with catering staff, like mealtime assistance, as important factors. The MUMC+ has adapted it's in-hospital meal system and the present study will evaluate the impact of this novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation.\n\nThe aim of this study is to assess whether a novel in-hospital meal concept can effectively increase daily total protein and energy intake during hospitalization, when compared to a historic control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (\\>18y) admitted to surgery nursing wards of the Maastricht University Medical Centre+ (MUMC+).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18y\n* Admitted to surgical nursing wards of MUMC+\n* Expected hospital stay of at least 3 days\n\nExclusion Criteria:\n\n* Receiving (par)enteral nutrition\n* "NPO" (nil per os) policy'}, 'identificationModule': {'nctId': 'NCT06399250', 'briefTitle': 'Three Channel Food Concept: the Effect Meal Service on Food Intake During Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Three Channel Food Concept: the Effect on Food Intake During Hospitalization (Dutch: Het Driekanalenconcept: Het Effect op Voedingsinname Tijdens Ziekenhuisopname)', 'orgStudyIdInfo': {'id': '302653'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'current in-hospital meal service', 'description': 'n=102 patients admitted to the Maastricht University Medical Centre+ (MUMC+) (surgical nursing wards) will be included.', 'interventionNames': ['Other: meal service']}, {'label': 'old in-hospital meal service', 'description': 'This will be an historic control group (data already collected in the past)'}], 'interventions': [{'name': 'meal service', 'type': 'OTHER', 'description': "We're not subjecting patients to an intervention, as we will evaluate the current in-hospital meal service. As the three channel food concept is standard of care, we're not subjecting patients to dietary or behavioral changes. We will compare the data to an historic control.", 'armGroupLabels': ['current in-hospital meal service']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'contacts': [{'name': 'Luc JC van Loon, PhD', 'role': 'CONTACT', 'email': 'l.vanloon@maastrichtuniversity.nl', 'phone': '+31-43-3881397'}], 'facility': 'Maastricht University Medical Centre', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Michelle EG Weijzen, PhD', 'role': 'CONTACT', 'email': 'm.weijzen@maastrichtuniversity.nl', 'phone': '0433887088'}], 'overallOfficials': [{'name': 'Luc JC van Loon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual raw data can be shared upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}