Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT03013803
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2016-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability Study on Nutricomp® Drink Plus Fibre in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004043', 'term': 'Dietary Fiber'}], 'ancestors': [{'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of gastrointestinal tolerance parameters', 'timeFrame': 'Day 1 - day 13'}], 'secondaryOutcomes': [{'measure': 'Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)', 'timeFrame': 'Day 1 - day 13'}, {'measure': 'Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang', 'timeFrame': 'Day 1 - day 13'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adult Patients in Need of High-energy Oral Nutritional Supplementation']}, 'descriptionModule': {'briefSummary': 'Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to show that it is acceptable for patients in the United Kingdom.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male and female participants ≥ 18 years of age\n* Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.\n* Anticipated period of nutritional support ≥ 12 days\n* Patient has the capacity and is willing to provide informed consent.\n\nExclusion criteria:\n\n* Participants with mental in capabilities who are unable to give informed consent\n* Hypersensitivity to any of the active substances or excipients within the IP\n* Severely impaired gastrointestinal function or complete failure\n* More than 50% of nutrition from Parenteral Nutrition\n* Simultaneous participation in another interventional study\n* Participants who are unwilling or mentally and/or physically unable to adhere to study procedures\n* Participants with dysphagia requiring thickened fluids\n* Participants with significant renal impairment (CKD)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03013803', 'acronym': 'Fuchsia', 'briefTitle': 'Acceptability Study on Nutricomp® Drink Plus Fibre in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Acceptability Study on Nutricomp® Drink Plus Fibre in Adults', 'orgStudyIdInfo': {'id': 'HC-G-H-1610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutricomp Drink Plus Fibre', 'description': 'Nutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate)', 'interventionNames': ['Dietary Supplement: Nutricomp Drink Plus Fibre']}], 'interventions': [{'name': 'Nutricomp Drink Plus Fibre', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Nutricomp Drink Plus Fibre']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS9 3AA', 'city': 'Leigh-on-Sea', 'country': 'United Kingdom', 'facility': 'AC Health & Nutrition Ltd', 'geoPoint': {'lat': 51.54297, 'lon': 0.64905}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}