Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-02-03 @ 2:04 AM
Study NCT ID:
NCT02959450
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aurora.serraldez@incmnsz.mx', 'phone': '+52-55-54870900', 'title': 'Dr. Aurora Serralde', 'phoneExt': '2193', 'organization': 'INCMNSZ'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adequacy of Oral Intake of Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '15', 'groupId': 'OG000'}, {'value': '36', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The energy intake measured in kcal/kg/d', 'unitOfMeasure': 'kcal/kg/d', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adequacy of Oral Intake of Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The protein intake measured in protein g/kg/d', 'unitOfMeasure': 'g/kg/d', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '12', 'groupId': 'OG000'}, {'value': '57', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The total of kg of body weight in the intervention group in contrast with the control group at 12 months of follow-up', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'number of deaths at 12 months of follow-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Swallowing Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': "Patient's swallowing ability evaluated by volume-viscosity test, if patient is able to swallow correctly the three types of consistencies (liquid, nectar and pudding)", 'unitOfMeasure': 'count of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'According to volume-viscosity test, number of patients that recovery the swallowing ability to eat safe'}, {'type': 'SECONDARY', 'title': 'BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '23', 'spread': '6.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Body mass index at the end of study', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'Patients who not agreed to participate or with severe oropharyngeal dysphagia (enteral feeding) was excluded'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Modified Consistency and Volume Diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.\n\nModified consistency and volume diet: Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '10', 'groupId': 'BG000'}, {'value': '71', 'spread': '11', 'groupId': 'BG001'}, {'value': '73', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Phase Angle (bioelectrical impedance)', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This measurement was taken with a multifrequency bioelectrical impedance analyser (Inbody S10). The outcome is the result from the arctg X (resistance)/R (reactance)', 'unitOfMeasure': 'degrees', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Handgrip strength', 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '9', 'groupId': 'BG000'}, {'value': '14', 'spread': '10', 'groupId': 'BG001'}, {'value': '15', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Energy intake', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '11', 'groupId': 'BG000'}, {'value': '27', 'spread': '10', 'groupId': 'BG001'}, {'value': '27', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kcal/kg/d', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Protein intake', 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/kg/d', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '12', 'groupId': 'BG000'}, {'value': '56', 'spread': '14', 'groupId': 'BG001'}, {'value': '56', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '22', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '21', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-10', 'size': 58180, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-11T20:50', 'hasProtocol': True}, {'date': '2021-10-10', 'size': 29609, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-11T20:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2016-11-07', 'resultsFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-07', 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequacy of Oral Intake of Energy', 'timeFrame': '12 months', 'description': 'The energy intake measured in kcal/kg/d'}, {'measure': 'Adequacy of Oral Intake of Protein', 'timeFrame': '12 months', 'description': 'The protein intake measured in protein g/kg/d'}], 'secondaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': '12 months', 'description': 'The total of kg of body weight in the intervention group in contrast with the control group at 12 months of follow-up'}, {'measure': 'Mortality', 'timeFrame': '12 months', 'description': 'number of deaths at 12 months of follow-up'}, {'measure': 'Swallowing Ability', 'timeFrame': '12 months', 'description': "Patient's swallowing ability evaluated by volume-viscosity test, if patient is able to swallow correctly the three types of consistencies (liquid, nectar and pudding)"}, {'measure': 'BMI', 'timeFrame': '12 months', 'description': 'Body mass index at the end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutritional Intervention in Oropharyngeal Dysphagia'], 'conditions': ['Oropharyngeal Dysphagia']}, 'referencesModule': {'references': [{'pmid': '15919036', 'type': 'RESULT', 'citation': 'Clave P, Verdaguer A, Arreola V. [Oral-pharyngeal dysphagia in the elderly]. Med Clin (Barc). 2005 May 21;124(19):742-8. doi: 10.1157/13075447. No abstract available. Spanish.'}, {'pmid': '24262954', 'type': 'RESULT', 'citation': 'Roden DF, Altman KW. Causes of dysphagia among different age groups: a systematic review of the literature. Otolaryngol Clin North Am. 2013 Dec;46(6):965-87. doi: 10.1016/j.otc.2013.08.008. Epub 2013 Oct 12.'}, {'pmid': '15255021', 'type': 'RESULT', 'citation': 'Clave P, Terre R, de Kraa M, Serra M. Approaching oropharyngeal dysphagia. Rev Esp Enferm Dig. 2004 Feb;96(2):119-31. doi: 10.4321/s1130-01082004000200005. No abstract available. English, Spanish.'}, {'pmid': '18789561', 'type': 'RESULT', 'citation': 'Clave P, Arreola V, Romea M, Medina L, Palomera E, Serra-Prat M. Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal dysphagia and aspiration. Clin Nutr. 2008 Dec;27(6):806-15. doi: 10.1016/j.clnu.2008.06.011. Epub 2008 Sep 11.'}, {'pmid': '10734019', 'type': 'RESULT', 'citation': 'Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. doi: 10.1016/s0016-5085(00)70137-5.'}, {'pmid': '19140539', 'type': 'RESULT', 'citation': 'Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.'}, {'pmid': '23588456', 'type': 'RESULT', 'citation': 'Burgos R, Sarto B, Segurola H, Romagosa A, Puiggros C, Vazquez C, Cardenas G, Barcons N, Araujo K, Perez-Portabella C. [Translation and validation of the Spanish version of the EAT-10 (Eating Assessment Tool-10) for the screening of dysphagia]. Nutr Hosp. 2012 Nov-Dec;27(6):2048-54. doi: 10.3305/nh.2012.27.6.6100. Spanish.'}, {'pmid': '11523474', 'type': 'RESULT', 'citation': 'Aviv JE, Sataloff RT, Cohen M, Spitzer J, Ma G, Bhayani R, Close LG. Cost-effectiveness of two types of dysphagia care in head and neck cancer: a preliminary report. Ear Nose Throat J. 2001 Aug;80(8):553-6, 558.'}, {'pmid': '24882372', 'type': 'RESULT', 'citation': 'Carrion S, Cabre M, Monteis R, Roca M, Palomera E, Serra-Prat M, Rofes L, Clave P. Oropharyngeal dysphagia is a prevalent risk factor for malnutrition in a cohort of older patients admitted with an acute disease to a general hospital. Clin Nutr. 2015 Jun;34(3):436-42. doi: 10.1016/j.clnu.2014.04.014. Epub 2014 May 9.'}, {'pmid': '14609974', 'type': 'RESULT', 'citation': 'Finestone HM, Greene-Finestone LS. Rehabilitation medicine: 2. Diagnosis of dysphagia and its nutritional management for stroke patients. CMAJ. 2003 Nov 11;169(10):1041-4.'}, {'pmid': '18239168', 'type': 'RESULT', 'citation': 'Jonsson AC, Lindgren I, Norrving B, Lindgren A. Weight loss after stroke: a population-based study from the Lund Stroke Register. Stroke. 2008 Mar;39(3):918-23. doi: 10.1161/STROKEAHA.107.497602. Epub 2008 Jan 31.'}, {'pmid': '17315085', 'type': 'RESULT', 'citation': 'Brynningsen PK, Damsgaard EM, Husted SE. Improved nutritional status in elderly patients 6 months after stroke. J Nutr Health Aging. 2007 Jan-Feb;11(1):75-9.'}, {'pmid': '11956839', 'type': 'RESULT', 'citation': 'Ekberg O, Hamdy S, Woisard V, Wuttge-Hannig A, Ortega P. Social and psychological burden of dysphagia: its impact on diagnosis and treatment. Dysphagia. 2002 Spring;17(2):139-46. doi: 10.1007/s00455-001-0113-5.'}, {'pmid': '20392703', 'type': 'RESULT', 'citation': 'Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. 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Nutr Clin Pract. 2013 Dec;28(6):639-50. doi: 10.1177/0884533613508435. Epub 2013 Oct 31.'}, {'pmid': '25850008', 'type': 'RESULT', 'citation': 'Clave P, Shaker R. Dysphagia: current reality and scope of the problem. Nat Rev Gastroenterol Hepatol. 2015 May;12(5):259-70. doi: 10.1038/nrgastro.2015.49. Epub 2015 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to design, implement and evaluate the effect of a nutritional intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of energy and protein.', 'detailedDescription': "Oropharyngeal Dysphagia causes complications that compromise the efficacy and security of deglutition. An inefficacy deglutition increases the risk of malnutrition and/or dehydration. On the other hand, unsafe deglutition requires more time to complete the oral preparation of the bolus, which can leave residues in the mouth that can then lead to penetration of small food particles into the respiratory tract. These tracheobronchial aspirations cause aspiration pneumonia in 50% of cases, with 50% of mortality rate.\n\nDespite the enormous impact of Oropharyngeal Dysphagia in functional capacity and quality of life, this problem is underestimated and underdiagnosed as a major cause of nutritional and pulmonary complications that generate more material and human resources. There are few studies evaluating the effect of a nutritional intervention on recovery in swallowing ability or improvement of nutritional status.\n\nThe purpose of this trial is to design a nutritional intervention with modified texture foods to increase viscosity (measured accurately) according to the patient's requirements, also assess if the intervention has a positive effect on the swallowing ability, calorie and protein oral intake and nutritional status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Oropharyngeal Dysphagia.\n* Patients who have primary caregiver.\n* Agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Critically ill patients.\n* Chronic kidney disease with Glomerular Filtration Rate \\<30 ml / min or in renal replacement therapy\n* Liver failure.\n* Cancer with active radiotherapy or chemotherapy treatment.\n* Patients who are participating in another study.'}, 'identificationModule': {'nctId': 'NCT02959450', 'briefTitle': 'Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind', 'orgStudyIdInfo': {'id': '1557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified consistency and volume diet', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP.', 'interventionNames': ['Dietary Supplement: Modified consistency and volume diet']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician'}], 'interventions': [{'name': 'Modified consistency and volume diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.', 'armGroupLabels': ['Modified consistency and volume diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Aurora E Serralde-Zúñiga, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Aurora Elizabeth Serralde Zúñiga', 'investigatorAffiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}