A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females With Compromised Iron Status
Lindenwood University
Summary
This randomized, double-blind, active-controlled trial will evaluate the effects of human lactoferrin supplementation combined with low-dose iron on iron status, aerobic performance, and lactate metabolism in exercising women with low ferritin. Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin \<35 µg/L will be enrolled in an 8-week intervention. Participants will be stratified by baseline ferritin status and randomized to receive 100 mg lactoferrin + 5 mg iron, 300 mg lactoferrin + 5 mg iron, or placebo + 5 mg iron daily. Primary outcomes include changes in ferritin and hematological parameters. Secondary outcomes include VO₂peak, time to exhaustion, and blood lactate responses during standardized treadmill testing. This study will determine whether lactoferrin enhances iron homeostasis and improves physiological and performance outcomes in exercising women with low iron stores.
Description
Iron deficiency is one of the most common micronutrient deficiencies in women, particularly among those who are physically active. Suboptimal iron status can impair oxygen transport, mitochondrial function, and exercise performance. Although oral iron supplementation is commonly used, gastrointestinal side effects may reduce adherence and limit effectiveness. Lactoferrin, an iron-binding glycoprotein, has emerged as a potential adjunct strategy to improve iron regulation and tolerability. This study will investigate whether supplementation with human recombinant lactoferrin in combination wit…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Women, 18 - 45 years of age * No changes in hormonal contraception use in the past 6 months * Has a regular menstrual cycle defined as five out of the past six months * Engaging in ≥5 hours per week of structured endurance exercise (e.g., running, cycling, swimming, rowing) for the past ≥6 months, with ≥3 sessions per week at moderate-to-vigorous intensity (≥70% HRmax or RPE ≥13). * Training must be consistent, with no interruptions \>2 consecutive weeks in the past 6 months and performed with the purpose of improving performance or preparing for a competition or persona…
Interventions
- Dietary SupplementLactoferrin 100 mg
Human recombinant lactoferrin administered at a dose of 100 mg daily for 8 weeks.
- Dietary SupplementLactoferrin 300 mg
Human recombinant lactoferrin administered at a dose of 300 mg daily for 8 weeks.
- Dietary SupplementIron Supplementation (5 mg)
Oral iron supplementation provided at a dose of 5 mg daily for 8 weeks.
Location
- Exercise and Performance Nutrition LaboratorySaint Charles, Missouri