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OpenTrials
Completed

NCT Number: NCT06428357

Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

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.

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Key information

Conditions

Exercise Performance

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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).

Treatment and study plan

Recombinant Bovine Lactoferrin

Dietary Supplement

Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.

Bovine Milk-Derived Lactoferrin

Dietary Supplement

Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.

Placebo

Dietary Supplement

Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.

Other names: Sugar Pill

Primary outcomes

  1. Change in serum iron (mcg/dL)

    Time frame: baseline to 4 weeks

    change in serum blood values obtained before and after supplementation

  2. Change in ferritin iron (ng/mL)

    Time frame: baseline to 4 weeks

    change in blood values obtained before and after supplementation

  3. Change in red blood cell count (trillion cells/L)

    Time frame: baseline to 4 weeks

    change in blood values obtained before and after supplementation

  4. change in iron binding capacity (mcg/dL)

    Time frame: baseline to 4 weeks

    change in blood values obtained before and after supplementation

Secondary outcomes

  1. change in time to exhaustion running (seconds)

    Time frame: baseline to 4 weeks

    change in treadmill running to exhaustion before and after supplementation

  2. change on tumor necrosis factor-a (pg/mL)

    Time frame: baseline to 4 weeks

    change in blood values obtained before and after supplementation

  3. change in interleukin-6 (pg/ml)

    Time frame: baseline to 4 weeks

    change in blood values obtained before and after supplementation

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • TurtleTree Labs Inc

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 24, 2024
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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