Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

Phase

N/A

Condition

N/A

Treatment

Bovine Milk-Derived Lactoferrin

Recombinant Bovine Lactoferrin

Placebo

Clinical Study ID

NCT06428357

23-3039

Ages 18-42
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 orexercising more than 2 days per week of

● For females specifically:

Pre-menopausal: experiencing a regular period with no signs of perimenopause ormenopause.

Exclusion

Exclusion Criteria:

Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or otherblood 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-monophasicoral 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 theiroriginal scheduled visits, but immune values will be excluded.
Vegan (due to supplement ingredients).

Study Design