Effects of Recombinant Bovine Lactoferrin on Iron Regulation and Exercise Performance
Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
This study is testing whether a special protein from cows can help healthy young adults improve their iron levels and exercise performance compared to regular milk protein and a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06428357 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy of recombinant bovine lactoferrin (rbLf) supplementation in healthy adults, focusing on its impact on iron regulation, gut health, and immune function. Participants will undergo a series of exercise tests and health assessments over 14 weeks, with a total of 110 individuals enrolled. The study compares the effects of rbLf to bovine milk-derived lactoferrin and a placebo. Inclusion criteria ensure participants are active adults aged 18-42 without iron-related medical conditions.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-42 who are physically active and have normal hemoglobin levels.
Not a fit: Patients with clinically diagnosed iron-deficiency anemia or other significant blood-related conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance iron regulation and exercise performance in healthy adults.
How similar studies have performed: Other studies have shown promising results with lactoferrin supplementation, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Chapel Hill, North Carolina
- Applied Physiology Laboratory — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Abbie Smith-Ryan, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Abbie E. Smith-Ryan, PhD
- Email: abbsmith@email.unc.edu
- Phone: 9199622574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.