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

NCT07546591 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Low Ferritin
  • Iron Deficiencies
  • Iron Deficiency
  • Exercise Performance of Fit Athletes

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.

Sponsors & Collaborators

  • Lindenwood University

    lead OTHER

Principal Investigators

  • Chad M Kerksick, PhD · Lindenwood University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546591 on ClinicalTrials.gov