Actively Recruiting
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
Led by Lindenwood University · Updated on 2026-04-27
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Have a regular menstrual cycle defined as five out of the past six months
- Engage in 6 hours per week of structured endurance exercise (e.g., running, cycling, swimming, rowing) for the past 6 months, with at least 3 sessions per week at moderate-to-vigorous intensity
- Consistent training with no interruptions over 2 consecutive weeks in the past 6 months aimed at performance or competition preparation
- Serum ferritin levels below 30 g/L indicating some degree of compromised iron status
- Participation in at least one organized endurance event or actively training for a planned competition within 6 months
- Generally healthy without gastrointestinal diseases
- No recent or acute infection in the past 30 days and no chronic systemic illness
- No psychiatric condition impairing consent or study adherence
- Stable psychiatric medication regimen for 3 months if applicable
- Body mass index between 18.5 and 32.5 kg/m2 inclusive
- Non-smoker
- Agree to not start new vitamin, mineral, or dietary supplements until after study completion and avoid supplements 24 hours before visits
- Willing and able to maintain consistent diet and physical activity habits
- Willing and able to provide informed consent and comply with study protocol
- Able to read and understand English at a 6th-grade level
You will not qualify if you...
- History of food allergies or intolerances affecting digestion or gastrointestinal disorders like irritable bowel syndrome, inflammatory bowel disease, gastroparesis, chronic constipation or diarrhea requiring medication, or GI surgery
- Medical conditions including bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥140/90 mmHg), kidney or liver impairment, diabetes type I or II, neurologic diseases affecting cognition or mood, unstable thyroid disease, chronic inflammatory or immune disorders, or any condition deemed exclusionary by the investigator
- Acute illness or infection within the past 30 days
- History of cancer (except localized skin cancer without spread) within 5 years prior to screening
- Recent start or dosage changes (within 90 days) of medications affecting study outcomes such as antihypertensives, hypoglycemics, GLP1 agonists, stimulatory asthma medications, or other relevant drugs
- Habitual use of anti-inflammatory medications within 30 days before providing samples
- Current or past diagnosis of severe psychiatric conditions including bipolar disorder, schizophrenia spectrum, or psychotic disorders; recent psychiatric hospitalization or suicidal behavior
- Changes in psychotropic medications within the past 3 months
- Allergy to any ingredients in the study products
- History of drug or alcohol abuse in the past 12 months
- Excessive alcohol intake defined as more than 7 drinks per week or binge episodes
- Any condition that could compromise participant safety or study data quality
- Participation in another research study within 30 days prior to screening that could affect results
- Currently pregnant or breastfeeding
AI-Screening
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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
CONTACT
J
Joesi M Morey, MS
CONTACT
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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