Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-02-18 @ 2:41 AM
Study NCT ID:
NCT03638661
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2018-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
n-3 Fatty Acids in Enteral Formula on NK Cell Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D008043', 'term': 'Linseed Oil'}, {'id': 'D013024', 'term': 'Soybean Oil'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-30', 'size': 231154, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-16T03:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The ready-to-use soybean used formula and n3EN formula had identical packaging with no differences in appearance, texture, or smell.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NK cell activity', 'timeFrame': 'Baseline', 'description': 'NK cell activity (%)'}], 'secondaryOutcomes': [{'measure': 'cytokine values', 'timeFrame': 'Baseline', 'description': '(IL-12, IFN-γ, IL-1β , IL-6 and TNF-α)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enteral Nutrition']}, 'descriptionModule': {'briefSummary': 'The aim of our study was to investigate the NK cell activity alternations and related cytokine changes in comparison with soybean oil used formula (control) and the canola and flaxseed oil used n-3 fatty acid enriched formula (n3EN, test) with non-surgical hospitalized patients for rehabilitation.', 'detailedDescription': 'Patients were randomized to receive one of two types of enteral nutrition formula: soybean oil used enteral nutrition (control), vegetable (canola, flaxseed) derived n-3 fatty acid enriched enteral nutrition (n3EN). Blood samples were collected on the first day and 14 days after consumption of each formula and anthropometric parameters were collected. Hematology and biochemical values were analyzed and NK cell activities and serum cytokine productions were measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were admitted to the Severance Hospital Rehabilitation Department , enteral tube feeding patient, Adult male and female patients aged 19 years and over, Patients who signed the consent form\n\nExclusion Criteria:\n\n* Patient with nausea\n* Patients with hepatic impairment (total bilirubin concentration\\> 3.5 mg / dl)\n* Patients with renal impairment (serum creatinine concentration\\> 3 mg / dl or requiring peritoneal or hemodialysis) diabetic patients\n* Patients who are undergoing chemotherapy or who are within 1 month of the end of chemotherapy\n* Patients whose life expectancy is less than 1 month\n* Pregnant women and women who are pregnant'}, 'identificationModule': {'nctId': 'NCT03638661', 'acronym': 'YS', 'briefTitle': 'n-3 Fatty Acids in Enteral Formula on NK Cell Activity', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Immune-enhancing Enteral Nutrition Formula Enriched With Vegetable Derived n-3 Fatty Acids on NK Cell Activity in Hospitalized Patients for Rehabilitation', 'orgStudyIdInfo': {'id': 'YS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'n-3 fatty acid enriched formula', 'description': 'Those assigned to the n3EN group received vegetable n-3 fatty acid enriched formula by tube feeding (product; Yonsei Dairy Co., Seoul, South Korea).\n\nvegetable (canola, flaxseed) derived n-3 fatty acid', 'interventionNames': ['Dietary Supplement: vegetable (canola, flaxseed) derived n-3 fatty acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'soybean oil used formula', 'description': 'Patients assigned to the control group received a soybean used formula by tube feeding.\n\nsoybean used formula', 'interventionNames': ['Dietary Supplement: soybean oil']}], 'interventions': [{'name': 'vegetable (canola, flaxseed) derived n-3 fatty acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'vegetable (canola, flaxseed) derived n-3 fatty acid was used for fat source.', 'armGroupLabels': ['n-3 fatty acid enriched formula']}, {'name': 'soybean oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'soybean oil used formula', 'armGroupLabels': ['soybean oil used formula']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Principal Investigator', 'investigatorFullName': 'Jong Ho Lee', 'investigatorAffiliation': 'Yonsei University'}}}}