Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-04 @ 9:53 AM
Study NCT ID:
NCT02895204
Status:
COMPLETED
Last Update Posted:
2017-02-13
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fermented Maillard Reacted Whey Protein on Immune Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-09-04', 'lastUpdatePostDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Natural killer cell activity', 'timeFrame': 'At baseline'}, {'measure': 'Natural killer cell activity', 'timeFrame': 'At 8-week follow-up'}, {'measure': 'Change from baseline natural killer cell activity at 8-week', 'timeFrame': 'At baseline and 8-week follow-up'}], 'secondaryOutcomes': [{'measure': 'White blood cell', 'timeFrame': 'At baseline'}, {'measure': 'White blood cell', 'timeFrame': 'At 8-week follow-up'}, {'measure': 'Change from baseline white blood cell at 8-week', 'timeFrame': 'At baseline and 8-week follow-up'}, {'measure': 'Interleukin-12', 'timeFrame': 'At baseline'}, {'measure': 'Interleukin-12', 'timeFrame': 'At 8-week follow-up'}, {'measure': 'Change from baseline Interleukin-12 at 8-week', 'timeFrame': 'At baseline and 8-week follow-up'}, {'measure': 'Interferon-gamma', 'timeFrame': 'At baseline'}, {'measure': 'Interferon-gamma', 'timeFrame': 'At 8-week follow-up'}, {'measure': 'Change from baseline Interferon-gamma at 8-week', 'timeFrame': 'At baseline and 8-week follow-up'}]}, 'conditionsModule': {'keywords': ['Fermented Maillard reacted whey protein', 'Natural killer cell activity', 'Immune function', 'Pre-albumin', 'Interleukin-12'], 'conditions': ['Immune Deficiency']}, 'descriptionModule': {'briefSummary': 'To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on natural killer (NK) cell activity, circulating cytokines and serum protein levels.', 'detailedDescription': 'A randomized, double-blind, placebo-controlled study was conducted on 80 participant without diabetes and obesity. Over a 8-week testing period, the F-MRP group consumed 6 g of powder containing 4.2 g F-MRP each day, whereas the placebo group consumed the same amount with dextrin. NK cell activity (%) was measured based on the ratios of effector cells (E; peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562 cells) at E:T= 10:1, 5:1, 2.5:1, or 1.25:1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to give informed consent\n* The levels of white blood cells within range 3x10\\^3/μL\\~8x10\\^3/μL\n* Males and females\n* 20-70 years old\n* Without no severe complications\n\nExclusion Criteria:\n\n* Diabetes\n* White blood cell under 3x10\\^3/μL or over 8x10\\^3/μL\n* Pregnancy or breast-feeding\n* Hypersensitivity or disease history for milk protein\n* Liver disease, inflammation disease, or severe kidney failure disease\n* Cancer, lung disease, leukemia, or autoimmune disease\n* Psychological or neurological disease\n* Myocardiac infarction or cerebrovascular diseases within 6 months before screening\n* Consumption of other test products or drugs within 1 month before screening\n* Inflammation related disease within 1 month before screening'}, 'identificationModule': {'nctId': 'NCT02895204', 'briefTitle': 'Effect of Fermented Maillard Reacted Whey Protein on Immune Function', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Immune-enhancing Effect of Supplementation With Fermented Maillard Reacted Whey Protein in Nondiabetic and Nonobese Subjects', 'orgStudyIdInfo': {'id': 'SU_immune'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group (F-MRP)', 'description': 'Fermented Maillard reacted whey protein (F-MRP) supplementation', 'interventionNames': ['Dietary Supplement: Fermented Maillard reacted whey protein (F-MRP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo supplementation', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Fermented Maillard reacted whey protein (F-MRP)', 'type': 'DIETARY_SUPPLEMENT', 'description': '6g of powder containing 4.2g fermented maillard reacted whey protein', 'armGroupLabels': ['Test group (F-MRP)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '6g of maltodextrin', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong Ho Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}