Exercise Performance
Conditions
Keywords
Iron regulation
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.
Interventions
DIETARY_SUPPLEMENTRecombinant Bovine Lactoferrin
Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
DIETARY_SUPPLEMENTBovine Milk-Derived Lactoferrin
Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
DIETARY_SUPPLEMENTPlacebo
Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
Sponsors
TurtleTree Labs Inc
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-Blind
Intervention model description
Randomized cross-over design
Eligibility
Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum iron (mcg/dL) | baseline to 4 weeks | change in serum 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change on tumor necrosis factor-a (pg/mL) | baseline to 4 weeks | change in blood values obtained before and after supplementation |
| change in interleukin-6 (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 |
Countries
United States
Outcome results
None listed