Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · May 20, 2024
Trial Information
Current as of February 08, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a supplement called recombinant bovine lactoferrin (rbLf) on iron levels, exercise performance, gut health, and immune function in healthy adults. The goal is to see how well rbLf works compared to a different type of lactoferrin derived from cow's milk and a placebo (a harmless pill with no active ingredients). The trial is open to both men and women aged 18 to 42 who exercise regularly and meet certain health criteria, like having normal hemoglobin levels and a healthy body mass index.
Participants will need to attend six visits over 14 weeks, where they will undergo some exercises and tests to assess their fitness and iron levels. After an initial screening, they will be randomly assigned to receive either rbLf, bovine-milk derived lactoferrin, or a placebo for four weeks. Blood samples will be taken before and after the supplement phase to measure any changes. It's important to note that individuals with certain health conditions, allergies, or specific lifestyle factors (like being vegan) won't be eligible for the study. This trial is a great opportunity for eligible individuals to contribute to research that could help improve health and exercise performance.
Gender
ALL
Eligibility 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).
Trial Officials
Abbie Smith-Ryan, PhD
Principal Investigator
University of North Carolina, Chapel Hill
About University Of North Carolina, Chapel Hill
The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chapel Hill, North Carolina, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0