Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT02938234
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'At study days 1-8'}], 'primaryOutcomes': [{'measure': 'Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)', 'timeFrame': 'At screening examination (study days -3 to -1)', 'description': 'The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain'}, {'measure': 'Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)', 'timeFrame': 'At end of study (study day 8)', 'description': 'The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain'}, {'measure': "Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)", 'timeFrame': 'At study days 1-8', 'description': 'The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain'}], 'secondaryOutcomes': [{'measure': "Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)", 'timeFrame': 'At study day 1 and at study day 7', 'description': 'Assessment of palatability (using a 5-point hedonic-scale) regarding appearance, smell, taste, sweetness, mouthfeel and product in general'}, {'measure': 'Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)', 'timeFrame': 'At study days 1-7'}, {'measure': 'Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)', 'timeFrame': 'At study days 1-7'}, {'measure': 'Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS', 'timeFrame': 'At study days 1-7'}, {'measure': 'Use of ONS assessed by consumption time', 'timeFrame': 'At study days 1-7'}, {'measure': 'Use of ONS assessed by servings', 'timeFrame': 'At study days 1-7', 'description': 'Confirmation of intake'}, {'measure': 'Use of ONS assessed by presentation', 'timeFrame': 'At study days 1-7', 'description': 'Confirmation of serving temperature'}, {'measure': 'Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)', 'timeFrame': 'At study days 1-7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malnutrition', 'Geriatric subjects', 'Nursing home'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sex: male/female\n2. Age: 65 years or older\n3. Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m²\n4. Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition\n2. Subjects with galactosaemia or similar metabolic disorders\n3. Subjects with severely impaired gastrointestinal function or complete failure\n4. Subjects with insulin-requiring diabetes\n5. Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day)\n6. Subjects reporting frequent occurrence of migraine attacks\n7. Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia)\n8. Existing mouth abnormalities, which cause impaired gustatory sense\n9. Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication)\n10. Subjects passing through chemotherapy (last cycle \\< 2 months ago)\n11. Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS\n12. Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator\n13. Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition\n14. Subjects with need of a special diet contradicting the intake of the ONS\n15. History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders\n16. Subjects with dysphagia or with high aspiration risk\n17. Enrolment in another clinical study\n18. Administration of any investigational medicinal product during the last month prior to individual enrolment of the subject\n19. Subjects who are not able to self-report GI-problems and compliance\n20. Subjects who report a general dislike of the ONS flavour\n21. Subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned\n22. Subjects suspected or known not to follow instructions\n23. Subjects unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical study'}, 'identificationModule': {'nctId': 'NCT02938234', 'briefTitle': 'Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - ad Libitum Intake', 'orgStudyIdInfo': {'id': 'F3kc-001-CNI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-arm study', 'description': 'High caloric, high protein ONS, single dose of 400 kcal/day for 7 consecutive days, oral administration', 'interventionNames': ['Dietary Supplement: High caloric, high protein ONS']}], 'interventions': [{'name': 'High caloric, high protein ONS', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Single-arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99084', 'city': 'Erfurt', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'SocraTec R&D GmbH, Clinical Pharmacology Unit', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}], 'overallOfficials': [{'name': 'Cornelius Koch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SocraTec R&D GmbH, Clinical Pharmacology Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}