NCT06428357

Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

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 cow's milk derived bLf. Participants: 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. 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.

Conditions

• Exercise Performance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Recombinant Bovine Lactoferrin	Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
DIETARY_SUPPLEMENT	Bovine Milk-Derived Lactoferrin	Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
DIETARY_SUPPLEMENT	Placebo	Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.

Timeline

• Start date: 2024-07-05
• Primary completion: 2025-07-07
• Completion: 2025-07-07
• First posted: 2024-05-24
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States