Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 10:40 AM
Study NCT ID:
NCT04305860
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance of Different Thickeners in Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005421', 'term': 'Flavoring Agents'}, {'id': 'C002563', 'term': 'xanthan gum'}], 'ancestors': [{'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D005503', 'term': 'Food Additives'}, {'id': 'D000074385', 'term': 'Food Ingredients'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot study of nutritional intervention, randomized, and controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hydratation', 'timeFrame': '3 days during hospitalization', 'description': 'Volume of water ingested (ml)'}, {'measure': 'Taste', 'timeFrame': '3 days during hospitalization', 'description': 'Semiquantitative scale of Punctuation of taste: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).'}, {'measure': 'Odor', 'timeFrame': '3 days during hospitalization', 'description': 'Semiquantitative scale of Punctuation of odor: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).'}, {'measure': 'Appearance', 'timeFrame': '3 days during hospitalization', 'description': 'Semiquantitative scale of Punctuation of appearance: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).'}, {'measure': 'Overall valoration', 'timeFrame': '3 days during hospitalization', 'description': 'Quantiative scale of Punctuation: 0-10 points (very bad to very good).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thickener', 'Flavoring', 'Dysphagia'], 'conditions': ['Dysphagia', 'Dysphagia, Oropharyngeal']}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, pilot study of nutritional intervention to evaluate the acceptance to different kinds of thickeners, with and without the addition of flavoring.', 'detailedDescription': 'Background:\n\nIn patients with dyaphagia the modification of viscosity of oral liquids with thickeners ia needed to guarantee an effective and safe swallowing, and to ensure a proper state of hydration. There are two types of thickeners: thickeners obtained from modified starch or from food gums (suchxanthan gum)\n\nAim:\n\nTo evaluate the acceptance of different types of thickeners, with and without the addition of flavorings, and their relationship with water intake.\n\nMethods:\n\nRandomized, controlled, pilot study of nutritional intervention. Forty hospitalized patients with oropharyngeal dysphagia were randomized to 4 parallel groups: modified starch without flavoring, modified starch with flavoring, xanthan gum without flavoring, xanthan gum with flavoring. Each patient was asked to assess the odor, taste, appearance, and overall valoration of the thickened liquid with the different preparations, using a structured questionnaire. The number of glasses consumed by the patient over 3 consecutive days was also recorded to calculate de volume of liquid they consumed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with oropharyngeal dysphagia for liquids diagnosed before admission or during hospitalization and who need thickener.\n\nExclusion Criteria:\n\n* Patients with expected hospital length of stay less than 24 hours.\n* Patients with food allergy to any of the ingredients of the thickener or flavorings used in the study.\n* Patients with cognitive impairment that prevents collaborating in obtaining data.\n* Patients in terminal situations, in which death is expected in the following hours.'}, 'identificationModule': {'nctId': 'NCT04305860', 'briefTitle': 'Acceptance of Different Thickeners in Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'Complexo Hospitalario Universitario de A Coruña'}, 'officialTitle': 'Acceptance of Different Types of Thickeners, With and Without Flavoring, in Patients With Dysphagia', 'orgStudyIdInfo': {'id': '2019-527'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Modified starch without flavoring', 'description': 'Patients thicken water with modified starch during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake.', 'interventionNames': ['Dietary Supplement: Modified starch without flavoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modified starch with flavoring', 'description': 'Patients thicken water with modified starch adding any of 5 kinds of flavorings "Bi1 aromas" during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake.', 'interventionNames': ['Dietary Supplement: Mofidied starch with Bi1 aromas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xanthan gum without flavoring', 'description': 'Patients thicken water with xanthan gum during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake.', 'interventionNames': ['Dietary Supplement: Xanthan gum without flavoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xanthan gum with flavoring', 'description': 'Patients thicken water with xanthan gum adding any of 5 kinds of flavorings "Bi1 aromas" during 3 days of hospitalization.They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake.', 'interventionNames': ['Dietary Supplement: Xanthan gum with Bi1 aromas']}], 'interventions': [{'name': 'Modified starch without flavoring', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each patient of this group receives the thickener during three days of hospitalization', 'armGroupLabels': ['Modified starch without flavoring']}, {'name': 'Mofidied starch with Bi1 aromas', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization', 'armGroupLabels': ['Modified starch with flavoring']}, {'name': 'Xanthan gum without flavoring', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each patient of this group receives the thickener during three days of hospitalization', 'armGroupLabels': ['Xanthan gum without flavoring']}, {'name': 'Xanthan gum with Bi1 aromas', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization', 'armGroupLabels': ['Xanthan gum with flavoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15006', 'city': 'A Coruña', 'state': 'La Coruna', 'country': 'Spain', 'facility': 'Alfonso Vidal-Casariego', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Complexo Hospitalario Universitario de A Coruña', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alfonso Vidal Casariego', 'investigatorAffiliation': 'Complexo Hospitalario Universitario de A Coruña'}}}}