Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

NCT06428357 | Completed

• 1 other identifier: 23-3039
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Performance

Keywords

Iron regulation

Outcome Measures

Primary Outcomes (4)

• Change in serum iron (mcg/dL)

  change in serum blood values obtained before and after supplementation

  baseline to 4 weeks

• Change in ferritin iron (ng/mL)

  change in blood values obtained before and after supplementation

  baseline to 4 weeks

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

  change in blood values obtained before and after supplementation

  baseline to 4 weeks

• change in iron binding capacity (mcg/dL)

  change in blood values obtained before and after supplementation

  baseline to 4 weeks

Secondary Outcomes (3)

• change in time to exhaustion running (seconds)

  baseline to 4 weeks

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

  baseline to 4 weeks

• change in interleukin-6 (pg/ml)

  baseline to 4 weeks

Study Arms (4)

Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin

EXPERIMENTAL

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.

Dietary Supplement: Recombinant Bovine Lactoferrin; Dietary Supplement: Bovine Milk-Derived Lactoferrin

Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin

ACTIVE COMPARATOR

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.

Dietary Supplement: Recombinant Bovine Lactoferrin; Dietary Supplement: Bovine Milk-Derived Lactoferrin

Males: Recombinant Bovine Lactoferrin (rbLf), then placebo

ACTIVE COMPARATOR

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.

Dietary Supplement: Recombinant Bovine Lactoferrin; Dietary Supplement: Placebo

Males: Placebo, then recombinant bovine lactoferrin (rbLf)

PLACEBO COMPARATOR

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.

Dietary Supplement: Recombinant Bovine Lactoferrin; Dietary Supplement: Placebo

Interventions

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.

Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin; Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin; Males: Placebo, then recombinant bovine lactoferrin (rbLf); Males: Recombinant Bovine Lactoferrin (rbLf), then placebo

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.

Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin; Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin

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.

Also known as: Sugar Pill

Males: Placebo, then recombinant bovine lactoferrin (rbLf); Males: Recombinant Bovine Lactoferrin (rbLf), then placebo

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• TurtleTree Labs Inc: collaborator

Study Sites (1)

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cross-over design

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: July 5, 2024
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9-24 Months after publication
• Access Criteria: Clear specific study aims and ethics approval must be present.

Locations

US (1)