Recruiting

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

Sponsor:

Lindenwood University

Code:

NCT07546591

Conditions

Iron Deficiencies

Low Ferritin

Iron Deficiency

Exercise Performance of Fit Athletes

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Lactoferrin 100 mg

Lactoferrin 300 mg

Iron Supplementation (5 mg)

Study Details

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

Study ID

NCT07546591

Start date

Apr 30, 2026

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 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
Participants who become pregnant during the course of the study will be removed from participation
Willing and able to provide consent and comply with the protocol
Able to read and understand English at the 6th-grade level and sign the informed consent to participate in the study

Exclusion Criteria:

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
Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140/90 mmHg), renal or hepatic impairment/disease, Type I or II diabetes, any neurologic disease or disorder that may impact cognition or mood, unstable thyroid disease, chronic inflammatory conditions, immune disorders (such as HIV/AIDS), or any medical condition deemed exclusionary by the Principal Investigator (PI)
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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Lactoferrin 100 mg

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

Lactoferrin 300 mg

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

Iron Supplementation (5 mg)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Anthony M Hagele, MS

6369494785 ahagele@lindenwood.edu

Joesi M Morey, MS

jmorey@lindenwood.edu

Locations

Exercise and Performance Nutrition Laboratory

Recruiting

Saint Charles, Missouri, United States, 63301

Contacts

Anthony M Hagele, MS

6369494785 ahagele@lindenwood.edu

Joesi M Morey, MS

jmorey@lindenwood.edu

Principal Investigator:

Chad M Kerksick, PhD

More Information

Sponsor

Lindenwood University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lindenwood University on 2026-04-27.