Actively Recruiting
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females With Compromised Iron Status
Led by Lindenwood University · Updated on 2026-04-27
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how human lactoferrin combined with low-dose iron affects iron levels, aerobic fitness, and lactate metabolism in women who exercise and have low iron stores. The study focuses on healthy menstruating women aged 18 to 45 years with serum ferritin below 35 g/L, aiming to understand if lactoferrin can improve iron regulation and exercise outcomes. Iron deficiency is common in active women and can reduce oxygen delivery and exercise performance, making this study important for finding better supplementation methods. Participants will be randomly assigned to one of three groups for an 8-week period: receiving 100 mg lactoferrin plus 5 mg iron daily, 300 mg lactoferrin plus 5 mg iron daily, or a placebo plus 5 mg iron daily. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment. The intervention is oral supplementation taken daily, and participants will attend six visits including screening, baseline, and follow-ups at weeks 2, 4, 6, and 8. During the study, participants will undergo blood tests to measure iron biomarkers and blood parameters, along with assessments of aerobic capacity using treadmill tests measuring VO2peak, time to exhaustion, and blood lactate levels. Questionnaires will evaluate gastrointestinal symptoms, menstrual symptoms, quality of life, and recovery perception. Daily supplement adherence and any side effects will be monitored throughout. The primary outcome is the change in serum ferritin concentration over time, while secondary measures include changes in hemoglobin, hematocrit, red blood cell count, and exercise performance indicators.
CONDITIONS
Brief Title
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years
- No changes in hormonal contraception use in the past 6 months
- Regular menstrual cycle in at least five of the past six months
- Engaging in at least 5 hours per week of structured endurance exercise for the past 6 months
- Training consistently with no interruptions longer than 2 consecutive weeks in the past 6 months
- Serum ferritin levels below 30 g/L indicating some iron deficiency
- Participation in at least one organized endurance event or training for a competition within the next 6 months
- Generally healthy with no gastrointestinal diseases
- No recent or acute infection in the past 30 days
- Stable psychiatric medication regimen if applicable, with no recent changes
- Body mass index between 18.5 and 32.5 kg/m2
- Non-smoker
- Willing to avoid new supplements during the study and maintain consistent diet and activity
- Able to read and understand English and provide informed consent
- Not pregnant and agrees to leave the study if pregnancy occurs
You will not qualify if you...
- History of food allergies or intolerances affecting digestion or gastrointestinal disorders such as IBS, inflammatory bowel disease, gastroparesis, chronic constipation or diarrhea, or GI surgery
- Medical conditions including bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure, kidney or liver disease, diabetes, neurologic diseases affecting cognition or mood, unstable thyroid disease, chronic inflammatory or immune disorders
- Acute illness or infection within the past 30 days
- History of cancer (except localized skin cancer) within 5 years
- Recent start or dose change of medications that affect study outcomes
- Regular use of anti-inflammatory medications before screening
- Certain psychiatric diagnoses or recent psychiatric hospitalizations or medication changes
- Allergies to study product ingredients
- History of drug or alcohol abuse in the past 12 months
- Excessive alcohol consumption
- Participation in another research study within 30 days prior to screening
- Currently pregnant or breastfeeding
- Any condition assessed by the investigator as unsafe for participation or that could affect study data quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take daily supplements of lactoferrin combined with low-dose iron or placebo with iron for 8 weeks to evaluate effects on iron status and exercise performance.
6 visits including baseline and follow-ups at weeks 2, 4, 6, and 8
Trial Site Locations
Total: 1 location
1
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, United States, 63301
Actively Recruiting
Research Team
A
Anthony M Hagele, MS
J
Joesi M Morey, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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