Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
- Conditions
- Exercise Performance
- Registration Number
- NCT06428357
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
-
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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change in serum iron (mcg/dL) baseline to 4 weeks change in serum blood values obtained before and after supplementation
Change in red blood cell count (trillion cells/L) baseline to 4 weeks change in blood values obtained before and after supplementation
change in iron binding capacity (mcg/dL) baseline to 4 weeks change in blood values obtained before and after supplementation
Change in ferritin iron (ng/mL) baseline to 4 weeks change in blood values obtained before and after supplementation
- Secondary Outcome Measures
Name Time Method change on tumor necrosis factor-a (pg/mL) baseline to 4 weeks change in blood values obtained before and after supplementation
change in time to exhaustion running (seconds) baseline to 4 weeks change in treadmill running to exhaustion before and after supplementation
change in interleukin-6 (pg/ml) baseline to 4 weeks change in blood values obtained before and after supplementation
Trial Locations
- Locations (1)
Applied Physiology Laboratory
🇺🇸Chapel Hill, North Carolina, United States
Applied Physiology Laboratory🇺🇸Chapel Hill, North Carolina, United StatesAbbie Smith-RyanContact