Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-03 @ 6:51 PM
Study NCT ID:
NCT02569203
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2015-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Immune-enhancing Enteral Nutrition on Immunomodulation in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2015-09-24', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline NK cell activity at 7 days', 'timeFrame': 'at baseline and 7 days follow-up', 'description': 'NK cell activity (%)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline IL-12 at 7 days', 'timeFrame': 'at baseline and 7 days follow-up', 'description': 'IL-12 (pg/mL)'}, {'measure': 'Change from baseline hs-CRP at 7 days', 'timeFrame': 'at baseline and 7 days follow-up', 'description': 'hs-CRP (mg/dL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '27271657', 'type': 'DERIVED', 'citation': 'Lee JG, Kim YS, Lee YJ, Ahn HY, Kim M, Kim M, Cho MJ, Cho Y, Lee JH. Effect of Immune-Enhancing Enteral Nutrition Enriched with or without Beta-Glucan on Immunomodulation in Critically Ill Patients. Nutrients. 2016 Jun 2;8(6):336. doi: 10.3390/nu8060336.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients.', 'detailedDescription': 'To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients. In a randomized double-blind placebo-controlled study, 30 patients consumed 1 of 3 enteral nutrition: control, enteral nutrition of immune modulating nutrients enriched with β-glucan (250mg/L) or enteral nutrition of immune modulating nutrients without β-glucan. Enteral nutrition was initiated within 24 hours of ICU admission and continued during the ICU stay for a 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients\n\nExclusion Criteria:\n\n* ICU patients who could not receiving enteral nutrition'}, 'identificationModule': {'nctId': 'NCT02569203', 'briefTitle': 'Effect of Immune-enhancing Enteral Nutrition on Immunomodulation in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effects of Enteral Formula Including Immune-modulating Nutrients on Clinical Course and Immune Function in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'BT_ICU_immune'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'standard enteral nutrition', 'interventionNames': ['Dietary Supplement: standard enteral nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'test group I', 'description': 'high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan', 'interventionNames': ['Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan']}, {'type': 'EXPERIMENTAL', 'label': 'test group II', 'description': 'high-protein enteral nutrition of immune modulating nutrients without β-glucan', 'interventionNames': ['Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients without β-glucan']}], 'interventions': [{'name': 'standard enteral nutrition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['control group'], 'description': 'standard enteral nutrition', 'armGroupLabels': ['control group']}, {'name': 'high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['test group I'], 'description': 'high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan', 'armGroupLabels': ['test group I']}, {'name': 'high-protein enteral nutrition of immune modulating nutrients without β-glucan', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['test group II'], 'description': 'high-protein enteral nutrition of immune modulating nutrients without β-glucan', 'armGroupLabels': ['test group II']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jong Ho Lee, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Food and Nutrition, College of Human Ecology, Yonsei University, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-749, South Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}