Lactoferrin with low-dose iron to boost iron levels and aerobic fitness in active women
Official title: A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females With Compromised Iron Status
Run by Lindenwood University · NCT07546591 · Data updated 2026-11-12
We will test whether taking lactoferrin with a small daily dose of iron helps raise iron stores and improve aerobic performance in menstruating women with low ferritin.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Lindenwood University Academic / other |
| Locations | 1 site (Saint Charles, Missouri) |
| Status | Recruiting |
| Started | May 4, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07546591 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Menstruating women aged 18–45 who regularly do endurance training (≥5 hours/week), are actively training for competition, and have low ferritin (<35 µg/L) are the best fit for this trial.
✕Probably not a fit
Women who are not menstruating, who have normal or high ferritin, who need higher-dose iron therapy for iron-deficiency anemia, or who cannot attend in-person visits are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, parallel-group pilot will enroll about 30 healthy, menstruating women aged 18–45 who perform ≥5 hours/week of structured endurance exercise and have low ferritin (<35 µg/L). Participants are stratified by baseline ferritin (<20 vs 20–35 µg/L) and randomized to 100 mg lactoferrin + 5 mg iron, 300 mg lactoferrin + 5 mg iron, or placebo + 5 mg iron daily for 8 weeks. Primary outcomes are changes in ferritin and hematological parameters, and secondary outcomes include VO2peak, time-to-exhaustion, and blood lactate responses assessed during standardized treadmill testing with serial venous blood sampling. The protocol includes six in-person visits (screening, baseline, and weeks 2, 4, 6, and 8) to monitor biomarkers, inflammation, and performance measures.
Why it matters
Potential benefit: If successful, adding lactoferrin could help improve iron stores and exercise performance using lower iron doses and possibly reduce gastrointestinal side effects.
How similar studies have gone: Small clinical and mechanistic studies have suggested lactoferrin can improve iron absorption or iron status in some populations, but evidence specifically in exercising women is limited and this application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, United States Recruiting
Study contacts
- Principal investigator: Chad M Kerksick, PhD — Lindenwood University
- Study coordinator: Anthony M Hagele, MS
- Email: ahagele@lindenwood.edu
- Phone: 6369494785
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.