Trials
Search / Trial NCT06428357

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

Iron Regulation

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.

Locations

Chapel Hill, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0