Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

Not Applicable

Recruiting

• Conditions: Exercise Performance

• Registration Number: NCT06428357
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Inclusion Criteria:<br><br> - 18-42 years<br><br> - Body mass index less than 35 kg/m^2<br><br> - Finger prick hemoglobin levels fitting within normal range<br><br> - Males: 14-18g/dL<br><br> - Females: 12-16g/dL<br><br> - Active: meeting American College of Sports Medicine exercise guidelines or<br> exercising more than 2 days per week of<br><br> ? For females specifically:<br><br> - Pre-menopausal: experiencing a regular period with no signs of perimenopause or<br> menopause.<br><br>Exclusion Criteria:<br><br> - Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or other<br> blood or iron related medical conditions.<br><br> - Allergy or intolerance to milk, egg, soy, peanut, wheat, coconut, or almond dairy<br><br> - Smokers or vapers of nicotine or nicotine products<br><br> - Immunocompromised or diagnosed with Type I or II diabetes<br><br> - Irritable Bowel Disease, Crohn's disease, Celiacs<br><br> - Bowel movements less than three times per week, or clinically constipated<br><br> - Oral contraceptive users that have combined iron supplementation, or non-monophasic<br> oral contraceptive users.<br><br> - Pregnant or nursing<br><br> - Chronic eczema or clinically diagnosed asthma.<br><br> - Current antibiotic use or antibiotic use within the past 6 weeks<br><br> - If flu, corona virus, or cold occurs, subject will remain in the study with their<br> original scheduled visits, but immune values will be excluded.<br><br> - Vegan (due to supplement ingredients).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in serum iron (mcg/dL);Change in ferritin iron (ng/mL);Change in red blood cell count (trillion cells/L);change in iron binding capacity (mcg/dL)

Secondary Outcome Measures

Name	Time	Method
change in time to exhaustion running (seconds);change on tumor necrosis factor-a (pg/mL);change in interleukin-6 (pg/ml)