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

NCT07546591 | Recruiting

• 1 other identifier: IRB-26-88
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

lactoferrin; effera; iron supplementation; iron metabolism; ferritin; aerobic performance; vo2peak; endurance exercise; time to exhaustion; lactate metabolism; female athletes; exercising females; menstruating women; iron bioavailability; nutritional supplementation

Outcome Measures

Primary Outcomes (1)

• Change in Serum Ferritin Concentration

  Serum ferritin concentration will be assessed via venous blood samples to evaluate changes in iron storage over the intervention period.

  Baseline, Weeks 2, 4, 6, and 8

Secondary Outcomes (15)

• Change in Hemoglobin

  Baseline, Weeks 2, 4, 6, and 8

• Change in Hematocrit

  Baseline, Weeks 2, 4, 6, and 8

• Change in Red Blood Cell Count

  Baseline, Weeks 2, 4, 6, and 8

• Change in Serum Iron

  Baseline, Weeks 2, 4, 6, and 8

• Change in Total Iron Binding Capacity

  Baseline, Weeks 2, 4, 6, and 8

Study Arms (3)

Low-Dose Lactoferrin + Iron

EXPERIMENTAL

Participants will consume 100 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks.

Dietary Supplement: Lactoferrin 100 mg; Dietary Supplement: Iron Supplementation (5 mg)

High-Dose Lactoferrin + Iron

EXPERIMENTAL

Participants will consume 300 mg human lactoferrin (effera®) combined with 5 mg iron daily for 8 weeks.

Dietary Supplement: Lactoferrin 300 mg; Dietary Supplement: Iron Supplementation (5 mg)

Placebo + Iron

PLACEBO COMPARATOR

Participants will consume a placebo combined with 5 mg iron daily for 8 weeks.

Dietary Supplement: Iron Supplementation (5 mg)

Interventions

Lactoferrin 100 mg DIETARY_SUPPLEMENT

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

Low-Dose Lactoferrin + Iron

Lactoferrin 300 mg DIETARY_SUPPLEMENT

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

High-Dose Lactoferrin + Iron

Iron Supplementation (5 mg) DIETARY_SUPPLEMENT

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

High-Dose Lactoferrin + Iron; Low-Dose Lactoferrin + Iron; Placebo + Iron

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 personal goal.
• Exhibit some degree of compromised iron status as depicted by serum ferritin levels below 30 ug/L
• Participation in at least one organized endurance event (e.g., races, competitions, or matches) at the recreational, sub-elite, or elite level, or be actively training for a planned competition within the next 6 months.
• Generally healthy and free of diseases or disorders that impact functioning of the gastrointestinal system.
• No recent or acute infection in the past 30 days and no chronic systemic illness
• No psychiatric condition that, in the investigator's judgment, would impair consent capacity, protocol adherence, or valid completion of questionnaires.
• If psychiatric medication is used: stable regimen for ≥3 months with no anticipated changes during the study
• Body mass index (BMI) 18.5 to 32.5 kg/m2 (Inclusive)
• Non-smoker
• Agrees to not use any new vitamin, mineral, or dietary supplement product until after study completion and to not take any vitamins, minerals or dietary supplements 24 hours prior to any of the study visits.
• Willing and able to maintain consistent diet and physical activity habits

You may not qualify if:

• History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel disease (Crohn's, ulcerative colitis, celiac), gastroparesis, chronic constipation or diarrhea requiring medication, or GI surgery
• Acute illness or infection within the past 30 days
• History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
• Recently started taking (within the past 90 days or has had their dosage adjusted in the past 90 days) antihypertensives, hypoglycemic medications, GLP1 agonists of any class or type, stimulatory asthma medications, or any other prescription or over-the-counter medication that confound the outcomes measured in this study
• Habitual use of anti-inflammatory medications for 30 days prior to providing
• Current or past diagnosis of bipolar I/II disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, attempt, or self-harm behavior in the past 12 months
• Initiation, discontinuation, or dose change of any psychotropic medication within the past 3 months, including antidepressants, anxiolytics, antipsychotics, mood stabilizers, stimulants, or sedative-hypnotics
• Subject has an allergy to any ingredients in the study product
• Subject has a history of drug or alcohol abuse in the past 12 months
• Excessive alcohol intake defined as greater than 7 drinks/week or binge episodes
• Any condition or abnormality that in the expert opinion of the PI, participation in the study would compromise the safety of the subject or the quality of the study data.
• Participating in or has participated in another research study within 30 days prior to the screening visit that could confound outcomes
• Currently pregnant or lactating

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony M Hagele, MS

CONTACT

6369494785; ahagele@lindenwood.edu

Joesi M Morey, MS

CONTACT

jmorey@lindenwood.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and study investigators will be blinded to group assignment. Supplements will be provided in identical-appearing forms and labeled by a third party to ensure concealment of allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be stratified by baseline ferritin status (\<20 µg/L or 20-35 µg/L) and randomized in a parallel-group design to receive one of three interventions for 8 weeks: (1) 100 mg human lactoferrin + 5 mg iron, (2) 300 mg human lactoferrin + 5 mg iron, or (3) placebo + 5 mg iron. All groups will consume their assigned supplement daily throughout the intervention period.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 23, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)