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

Part of paid clinical trials in Saint Charles, Missouri.

Sponsor
Lindenwood University
Study ID
NCT07546591
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Lactoferrin 100 mg — DIETARY_SUPPLEMENT
    Human recombinant lactoferrin administered at a dose of 100 mg daily for 8 weeks.
  • Lactoferrin 300 mg — DIETARY_SUPPLEMENT
    Human recombinant lactoferrin administered at a dose of 300 mg daily for 8 weeks.
  • Iron Supplementation (5 mg) — DIETARY_SUPPLEMENT
    Oral iron supplementation provided at a dose of 5 mg daily for 8 weeks.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low-Dose Lactoferrin + Iron
    Participants will consume 100 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks.
  • Experimental: High-Dose Lactoferrin + Iron
    Participants will consume 300 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks.
  • Placebo Comparator: Placebo + Iron
    Participants will consume a placebo combined with 5 mg iron daily for 8 weeks.

Primary Outcome Measure

Change in Serum Ferritin Concentration [ Time Frame: Baseline, Weeks 2, 4, 6, and 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Exercise and Performance Nutrition LaboratorySaint CharlesMissouri63301
Anthony M Hagele, MS
[email protected]
6369494785
Joesi M Morey, MS
[email protected]
Chad M Kerksick, PhD (PRINCIPAL_INVESTIGATOR)

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Exercise and Performance Nutrition Laboratory· Saint Charles, MO

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