Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT06428357
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-Blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized cross-over design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-05-20', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum iron (mcg/dL)', 'timeFrame': 'baseline to 4 weeks', 'description': 'change in serum blood values obtained before and after supplementation'}, {'measure': 'Change in ferritin iron (ng/mL)', 'timeFrame': 'baseline to 4 weeks', 'description': 'change in blood values obtained before and after supplementation'}, {'measure': 'Change in red blood cell count (trillion cells/L)', 'timeFrame': 'baseline to 4 weeks', 'description': 'change in blood values obtained before and after supplementation'}, {'measure': 'change in iron binding capacity (mcg/dL)', 'timeFrame': 'baseline to 4 weeks', 'description': 'change in blood values obtained before and after supplementation'}], 'secondaryOutcomes': [{'measure': 'change in time to exhaustion running (seconds)', 'timeFrame': 'baseline to 4 weeks', 'description': 'change in treadmill running to exhaustion before and after supplementation'}, {'measure': 'change on tumor necrosis factor-a (pg/mL)', 'timeFrame': 'baseline to 4 weeks', 'description': 'change in blood values obtained before and after supplementation'}, {'measure': 'change in interleukin-6 (pg/ml)', 'timeFrame': 'baseline to 4 weeks', 'description': 'change in blood values obtained before and after supplementation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iron regulation'], 'conditions': ['Exercise Performance']}, 'descriptionModule': {'briefSummary': "Overall Objective: To determine the efficacy of rbLf supplementation in a healthy adult population, specifically with regard to iron regulation (primary), gut health (secondary), and immune function (secondary). Purpose: The purpose of this study is to determine the effects of rbLf on iron regulation, exercise performance, gut health, and immune function as compared to cow's milk derived bLf.\n\nParticipants: To account for an approximate \\~10% dropout rate (and rounding up to ensure equal number of enrolled participants per group), n=25 per group for males (N=50) and n=30 per group for females (N=60) will be enrolled for a total sample size of N=110.\n\nProcedures: Participation in this study will include 6 in-person visits over 14 weeks. Anemia will be checked and excluded at the first visit using a single finger prick, followed by a 10-20 min exercise test on a treadmill to evaluate exercise capacity. On visit 2 participants will perform three 3-15 minute exercise tests on a treadmill with rest in between each test in order to determine exercise performance. A finger prick will be performed before and after each run to determine lactate levels. After visits 2 participants will be randomized to their respective supplement group recombinant Bovine Lactoferrin supplement (rbLf) (Male and Fame), a bovine-milk derived Lactoferrin supplement (Female), or a placebo (Male) once daily for 4 weeks. Blood samples will be obtained prior to and after each supplement phase to determine change in iron levels and red blood cell capacity. After a 2-week washout participants will return to complete the same testing outcomes and will receive the subsequent supplement. At visit 6 a final blood sample will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-42 years\n* Body mass index less than 35 kg/m\\^2\n* Finger prick hemoglobin levels fitting within "normal range"\n\n * Males: 14-18g/dL\n * Females: 12-16g/dL\n* Active: meeting American College of Sports Medicine exercise guidelines or exercising more than 2 days per week of\n\n ● For females specifically:\n* Pre-menopausal: experiencing a regular period with no signs of perimenopause or menopause.\n\nExclusion Criteria:\n\n* Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or other blood or iron related medical conditions.\n* Allergy or intolerance to milk, egg, soy, peanut, wheat, coconut, or almond dairy\n* Smokers or vapers of nicotine or nicotine products\n* Immunocompromised or diagnosed with Type I or II diabetes\n* Irritable Bowel Disease, Crohn\'s disease, Celiacs\n* Bowel movements less than three times per week, or clinically constipated\n* Oral contraceptive users that have combined iron supplementation, or non-monophasic oral contraceptive users.\n* Pregnant or nursing\n* Chronic eczema or clinically diagnosed asthma.\n* Current antibiotic use or antibiotic use within the past 6 weeks\n* If flu, corona virus, or cold occurs, subject will remain in the study with their original scheduled visits, but immune values will be excluded.\n* Vegan (due to supplement ingredients).'}, 'identificationModule': {'nctId': 'NCT06428357', 'briefTitle': 'Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation', 'orgStudyIdInfo': {'id': '23-3039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin', 'description': 'After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start bovine milk derived lactoferrin for 4 weeks.', 'interventionNames': ['Dietary Supplement: Recombinant Bovine Lactoferrin', 'Dietary Supplement: Bovine Milk-Derived Lactoferrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin', 'description': 'After a 2-week run-in period, this arm will begin treatment with bovine milk derived lactoferrin and then following a 2-week washout start recombinant bovine lactoferrin for 4 weeks.', 'interventionNames': ['Dietary Supplement: Recombinant Bovine Lactoferrin', 'Dietary Supplement: Bovine Milk-Derived Lactoferrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Males: Recombinant Bovine Lactoferrin (rbLf), then placebo', 'description': 'After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start placebo for 4 weeks.', 'interventionNames': ['Dietary Supplement: Recombinant Bovine Lactoferrin', 'Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Males: Placebo, then recombinant bovine lactoferrin (rbLf)', 'description': 'After a 2-week run-in period, this arm will begin treatment with placebo for 4 weeks and following a 2-week washout start recombinant bovine lactoferrin for 4 weeks.', 'interventionNames': ['Dietary Supplement: Recombinant Bovine Lactoferrin', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Recombinant Bovine Lactoferrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.', 'armGroupLabels': ['Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin', 'Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin', 'Males: Placebo, then recombinant bovine lactoferrin (rbLf)', 'Males: Recombinant Bovine Lactoferrin (rbLf), then placebo']}, {'name': 'Bovine Milk-Derived Lactoferrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.', 'armGroupLabels': ['Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin', 'Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Sugar Pill'], 'description': 'Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.', 'armGroupLabels': ['Males: Placebo, then recombinant bovine lactoferrin (rbLf)', 'Males: Recombinant Bovine Lactoferrin (rbLf), then placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Applied Physiology Laboratory', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Abbie Smith-Ryan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '9-24 Months after publication', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina. Additionally, clear aims and scope of the data request must be included.', 'accessCriteria': 'Clear specific study aims and ethics approval must be present.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'TurtleTree Labs Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}