Clinical trial NCT06428357: Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
Official title: Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Performance
Keywords: Iron regulation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: TurtleTree Labs Inc
First posted: 2024-05-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cross-over design
Primary purpose: OTHER

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.


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).

Primary outcomes:
measure: Change in serum iron (mcg/dL)
timeFrame: baseline to 4 weeks
measure: Change in ferritin iron (ng/mL)
timeFrame: baseline to 4 weeks
measure: Change in red blood cell count (trillion cells/L)
timeFrame: baseline to 4 weeks
measure: change in iron binding capacity (mcg/dL)
timeFrame: baseline to 4 weeks
Secondary outcomes:
measure: change in time to exhaustion running (seconds)
timeFrame: baseline to 4 weeks
measure: change on tumor necrosis factor-a (pg/mL)
timeFrame: baseline to 4 weeks
measure: change in interleukin-6 (pg/ml)
timeFrame: baseline to 4 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Applied Physiology Laboratory
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Abbie Smith-Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: