Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

Exercise Performance Clinical Trial

Official title:

Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428357
• Other study ID #: 23-3039
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Abbie E. Smith-Ryan, PhD
• Phone: 9199622574
• Email: abbsmith[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

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).

Related Conditions & MeSH terms

• Exercise Performance

Intervention

Dietary Supplement:
• Recombinant Bovine Lactoferrin
Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.
• Bovine 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.
• Placebo
Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.

Locations

Country	Name	City	State
United States	Applied Physiology Laboratory	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	TurtleTree Labs Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum iron (mcg/dL)	change in serum blood values obtained before and after supplementation	baseline to 4 weeks
Primary	Change in ferritin iron (ng/mL)	change in blood values obtained before and after supplementation	baseline to 4 weeks
Primary	Change in red blood cell count (trillion cells/L)	change in blood values obtained before and after supplementation	baseline to 4 weeks
Primary	change in iron binding capacity (mcg/dL)	change in blood values obtained before and after supplementation	baseline to 4 weeks
Secondary	change in time to exhaustion running (seconds)	change in treadmill running to exhaustion before and after supplementation	baseline to 4 weeks
Secondary	change on tumor necrosis factor-a (pg/mL)	change in blood values obtained before and after supplementation	baseline to 4 weeks
Secondary	change in interleukin-6 (pg/ml)	change in blood values obtained before and after supplementation	baseline to 4 weeks