Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428357
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-20
Brief Title:
Efficacy of Recombinant Bovine Lactoferrin rbLf in Iron Regulation
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Efficacy of Recombinant Bovine Lactoferrin rbLf in Iron Regulation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 cows milk derived bLf
Participants To account for an approximate 10 dropout rate and rounding up to ensure equal number of enrolled participants per group n25 per group for males N50 and n30 per group for females N60 will be enrolled for a total sample size of N110
Procedures 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
Participants To account for an approximate 10 dropout rate and rounding up to ensure equal number of enrolled participants per group n25 per group for males N50 and n30 per group for females N60 will be enrolled for a total sample size of N110
Procedures 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None