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Lactoferrin and Iron for Exercising Women with Low Iron

This study is looking at how two different doses of lactoferrin (an iron-binding protein) combined with a small amount of iron supplementation affect iron levels and exercise performance in women who exercise regularly and have low ferritin (a protein that stores iron). You might be able to join if you are a woman between 18 and 45 years old, have regular periods, exercise at least 5 hours a week, and have low ferritin levels (below 35 micrograms per liter). The researchers want to see if these supplements can improve your iron storage, which they will measure by checking your serum ferritin concentration over 8 weeks. The study aims to enroll about 30 participants.

Study design
This is a randomized, double-blind, active-controlled study with about 30 participants. You would be randomly assigned to receive one of three daily treatments for 8 weeks: 100 mg lactoferrin plus 5 mg iron, 300 mg lactoferrin plus 5 mg iron, or a placebo (inactive substance) plus 5 mg iron.
What's involved
You would have six study visits over 8 weeks, including screening, a baseline visit, and follow-up visits at weeks 2, 4, 6, and 8. These visits will include blood draws to check your iron levels and other markers, as well as treadmill tests to assess your exercise performance.
Compensation
Not stated in the trial record.
Follow-up
Your iron levels and other measurements will be tracked for 8 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07546591

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

Recruiting
NAAges 18–45InterventionalTreatment
Lindenwood University
~30 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Lactoferrin 100 mgLactoferrin 300 mgIron Supplementation (5 mg)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Serum Ferritin Concentration
Measured over Baseline, Weeks 2, 4, 6, and 8

Conditions

Iron Deficiencies
Low Ferritin
Iron Deficiency
Exercise Performance of Fit Athletes

Explore related trials

Iron Deficiency

NCT07546591

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Exercise and Performance Nutrition Laboratory

    Saint Charles, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Chad M Kerksick, PhD · PRINCIPAL_INVESTIGATOR · Lindenwood University

Who to contact

Anthony M Hagele, MS
[email protected]
6369494785
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Serum Ferritin ConcentrationBaseline, Weeks 2, 4, 6, and 8

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