Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

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

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.

Sponsors & Collaborators

• TurtleTree Labs Inc

  collaborator UNKNOWN

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Abbie Smith-Ryan, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

42 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-05

Primary Completion

2025-07-07

Completion

2025-07-07

Countries

• United States

Study Locations