Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-01 @ 10:24 PM
Study NCT ID:
NCT02763904
Status:
COMPLETED
Last Update Posted:
2024-11-18
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '7 days', 'description': 'Change in phase angle as assessed by vectorial impedance analysis'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '14 days', 'description': 'Change in phase angle as assessed by vectorial impedance analysis'}, {'measure': 'Body composition', 'timeFrame': 'Hospital stay, an average of 17 days', 'description': 'Change in phase angle as assessed by vectorial impedance analysis'}, {'measure': 'Functional status', 'timeFrame': '7 days', 'description': 'Change in handgrip strength as assessed by dynamometry'}, {'measure': 'Functional status', 'timeFrame': '14 days', 'description': 'Change in handgrip strength as assessed by dynamometry'}, {'measure': 'Functional status', 'timeFrame': 'Hospital stay, an average of 17 days', 'description': 'Change in handgrip strength as assessed by dynamometry'}, {'measure': 'Energy intake', 'timeFrame': '7 days', 'description': 'Protein-calorie intake as assessed by serial 24-hour dietary recall'}, {'measure': 'Energy intake', 'timeFrame': '14 days', 'description': 'Protein-calorie intake as assessed by serial 24-hour dietary recall'}, {'measure': 'Infections', 'timeFrame': 'Hospital stay, an average of 17 days', 'description': 'Incidence of new infections during the hospital stay'}, {'measure': 'Adverse events', 'timeFrame': 'Hospital stay, an average of 17 days', 'description': 'Gastrointestinal intolerance events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutritional Support']}, 'descriptionModule': {'briefSummary': "Protein-calorie malnutrition is a frequent comorbidity in hospitalized patients and there is evidence that the nutritional status may influence the response to drug treatment, mortality, susceptibility to infections, the patient's functional status, duration of hospital stay and, consequently, overall healthcare costs. The causes of malnutrition are manifold. The underlying disease may in fact lead to an increase in the patient's energy needs, whether or not associated with a reduction in caloric intake. The same therapeutic treatments can further worsen the energy balance without considering that the patient can be kept fasting for the execution of some diagnostic procedures. Therefore, a further deterioration of nutritional status during hospitalization could occur.\n\nInternational guidelines underline the utility to set a nutritional support whenever this is necessary, not only to prevent or treat malnutrition but also improve clinical outcomes. In this perspective, the improvement of oral diet and the use of oral nutritional supplements (ONS) represent the first-line strategy of intervention. Previous studies have shown that nutritional counseling, with or without the use of ONS, in patients with chronic disease is able to improve the calorie-protein intake, prevent deterioration of nutritional status, as well as to increase to a certain extent body weight. Particularly, energy-dense are more effective in increase energy intake. These data have highlighted the importance of a proper evaluation of the nutritional status of early detection of patients who could benefit of nutritional support. However, the independent role of the ONS in improving clinical outcome still needs to be established."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nutritional Risk Score \\[NRS-2002\\] ≥3\n* assessed within 48 hours since admission\n* expected length of stay ≥7 days\n* written informed consent\n\nExclusion Criteria:\n\n* age \\< 18 years\n* ongoing or indication to artificial nutrition\n* severe hypophagia (intake \\<50% of estimated requirements)\n* scheduled for surgery\n* indication to fasting\n* physician-based contra-indication to use of liquid oral nutritional supplements (vomitus, severe nausea, diarrhea, dysphagia)\n* physician-based indication to the of disease-specific oral nutritional supplements (e.g. kidney failure or pressure ulcers)\n* terminal illness\n* unavailability to planned measurements'}, 'identificationModule': {'nctId': 'NCT02763904', 'briefTitle': 'Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk Receiving Dietary Counseling: a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '20150005564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive nutritional counseling', 'description': 'Dietary counseling + energy dense oral nutritional supplements', 'interventionNames': ['Dietary Supplement: Intensive nutritional counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary counseling', 'description': 'Dietary counseling', 'interventionNames': ['Other: Dietary counseling']}], 'interventions': [{'name': 'Intensive nutritional counseling', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary counseling + energy-dense oral nutritional supplements since admission', 'armGroupLabels': ['Intensive nutritional counseling']}, {'name': 'Dietary counseling', 'type': 'OTHER', 'description': 'Dietary counseling alone. In case of inadequate energy intake patients will receive oral nutritional supplements since day 8 from admission (after the evaluation of the primary end point)', 'armGroupLabels': ['Dietary counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Emanuele Cereda, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo'}, {'name': 'Riccardo Caccialanza, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione IRCCS Policlinico San Matteo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emanuele Cereda', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'investigatorFullName': 'Emanuele Cereda', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}