Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-06-24 @ 2:31 AM
Study NCT ID:
NCT04703894
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Acceptability Evaluation AYMES Cardiff
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastro-Intestinal Tolerance when consuming AYMES CARDIFF', 'timeFrame': '30 days', 'description': "To assess gastro-intestinal tolerance of 'CARDIFF' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number of any GI complaints via a daily diary."}], 'secondaryOutcomes': [{'measure': 'Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire', 'timeFrame': '30 days', 'description': "To assess the acceptability of 'CARDIFF' in patients in the community requiring oral nutritional supplementation. At the end of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new supplement drink. A 5 point hedonic scale will be used."}, {'measure': 'Compliance', 'timeFrame': '30 days', 'description': "To assess the compliance of patients to 'CARDIFF' by daily completion of a compliance diary, comparing consumed versus prescribed amount."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': "To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives.", 'detailedDescription': "To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.\n\nTo obtain data to support an ACBS submissions for 'CARDIFF' (to allow for prescription in the community at NHS expense)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients.\n* ≥ 18 years of age.\n* Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 30 days.\n* Patient is able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with medical or dietary contraindication to any feed ingredients.\n* Patients requiring sole enteral tube feeding or parenteral nutrition.\n* Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)\n* Patients with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.\n* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.\n* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.\n* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.'}, 'identificationModule': {'nctId': 'NCT04703894', 'briefTitle': 'Tolerance and Acceptability Evaluation AYMES Cardiff', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aymes International Limited'}, 'officialTitle': 'Tolerance and Acceptability Evaluation AYMES Cardiff', 'orgStudyIdInfo': {'id': 'AY:CAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "AYMES 'CARDIFF'", 'description': "Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'CARDIFF' for a period of 30 days.", 'interventionNames': ["Dietary Supplement: AYMES 'CARDIFF'"]}], 'interventions': [{'name': "AYMES 'CARDIFF'", 'type': 'DIETARY_SUPPLEMENT', 'description': 'AYMES CARDIFF is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.', 'armGroupLabels': ["AYMES 'CARDIFF'"]}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RH16 9PL', 'city': 'Haywards Heath', 'country': 'United Kingdom', 'facility': 'AYMES International Ltd.', 'geoPoint': {'lat': 50.99769, 'lon': -0.10313}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aymes International Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}