Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

Not Applicable

Recruiting

• Conditions: Exercise Performance
• Interventions: Dietary Supplement: Recombinant Bovine Lactoferrin; Dietary Supplement: Placebo; Dietary Supplement: Bovine Milk-Derived Lactoferrin

• Registration Number: NCT06428357
• Lead Sponsor: University of North Carolina, Chapel Hill

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Study Start: 2024-07-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 18-42 years

• Body mass index less than 35 kg/m^2

• Finger prick hemoglobin levels fitting within "normal range"

  • Males: 14-18g/dL
  • Females: 12-16g/dL

• Active: meeting American College of Sports Medicine exercise guidelines or exercising more than 2 days per week of

  ● For females specifically:

• Pre-menopausal: experiencing a regular period with no signs of perimenopause or menopause.

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Exclusion Criteria

• Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or other blood or iron related medical conditions.
• Allergy or intolerance to milk, egg, soy, peanut, wheat, coconut, or almond dairy
• Smokers or vapers of nicotine or nicotine products
• Immunocompromised or diagnosed with Type I or II diabetes
• Irritable Bowel Disease, Crohn's disease, Celiacs
• Bowel movements less than three times per week, or clinically constipated
• Oral contraceptive users that have combined iron supplementation, or non-monophasic oral contraceptive users.
• Pregnant or nursing
• Chronic eczema or clinically diagnosed asthma.
• Current antibiotic use or antibiotic use within the past 6 weeks
• If flu, corona virus, or cold occurs, subject will remain in the study with their original scheduled visits, but immune values will be excluded.
• Vegan (due to supplement ingredients).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin	Recombinant Bovine Lactoferrin	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.
Males: Recombinant Bovine Lactoferrin (rbLf), then placebo	Placebo	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.
Males: Placebo, then recombinant bovine lactoferrin (rbLf)	Placebo	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.
Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin	Recombinant Bovine Lactoferrin	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.
Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin	Bovine Milk-Derived Lactoferrin	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.
Males: Recombinant Bovine Lactoferrin (rbLf), then placebo	Recombinant Bovine Lactoferrin	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.
Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin	Bovine Milk-Derived Lactoferrin	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.
Males: Placebo, then recombinant bovine lactoferrin (rbLf)	Recombinant Bovine Lactoferrin	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.

Primary Outcome Measures

Name	Time	Method
Change in serum iron (mcg/dL)	baseline to 4 weeks	change in serum blood values obtained before and after supplementation
Change in red blood cell count (trillion cells/L)	baseline to 4 weeks	change in blood values obtained before and after supplementation
Change in ferritin iron (ng/mL)	baseline to 4 weeks	change in blood values obtained before and after supplementation
change in iron binding capacity (mcg/dL)	baseline to 4 weeks	change in blood values obtained before and after supplementation

Secondary Outcome Measures

Name	Time	Method
change on tumor necrosis factor-a (pg/mL)	baseline to 4 weeks	change in blood values obtained before and after supplementation
change in time to exhaustion running (seconds)	baseline to 4 weeks	change in treadmill running to exhaustion before and after supplementation
change in interleukin-6 (pg/ml)	baseline to 4 weeks	change in blood values obtained before and after supplementation

Trial Locations

Locations (1)

Applied Physiology Laboratory; 🇺🇸 Chapel Hill, North Carolina, United States