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NOT YET RECRUITING
NCT07546591
NA

A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females

Sponsor: Lindenwood University

View on ClinicalTrials.gov

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.

Official title: A Randomized, Placebo-Controlled Pilot to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females With Compromised Iron Status

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-30

Completion Date

2027-04-30

Last Updated

2026-04-23

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Lactoferrin 100 mg

Human recombinant lactoferrin administered at a dose of 100 mg daily for 8 weeks.

DIETARY_SUPPLEMENT

Lactoferrin 300 mg

Human recombinant lactoferrin administered at a dose of 300 mg daily for 8 weeks.

DIETARY_SUPPLEMENT

Iron Supplementation (5 mg)

Oral iron supplementation provided at a dose of 5 mg daily for 8 weeks.

Locations (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, United States