Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

University of North Carolina (UNC)

Status: Enrolling

Conditions: Exercise Performance

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06428357

23-3039

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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110 participants in 4 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Recombinant Bovine Lactoferrin

Dietary Supplement: Bovine Milk-Derived Lactoferrin

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

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Recombinant Bovine Lactoferrin

Dietary Supplement: Bovine Milk-Derived Lactoferrin

Males: Recombinant Bovine Lactoferrin (rbLf), then placebo

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Recombinant Bovine Lactoferrin

Males: Placebo, then recombinant bovine lactoferrin (rbLf)

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Recombinant Bovine Lactoferrin