Encapsulated lactoferrin to boost iron absorption in women with iron deficiency
Iron Absorption From Stabilized Lactoferrin: An Experimental Study in Iron Deficient Women (LOBSTER)
This will test if encapsulating lactoferrin helps women with iron deficiency absorb iron from meals better than standard iron preparations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | ETH Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT07394972 on ClinicalTrials.gov |
What this trial studies
In a randomized crossover design, non-anemic women with low ferritin will consume meals containing different test compounds including iron sulfate with or without native or encapsulated lactoferrin variants. Each test compound is labeled with stable iron isotopes so that iron absorption can be traced and compared within participants. The trial compares multiple encapsulation methods (NaCas, LMP, and combinations with Fe) against a standard FeSO4 meal matrix to identify which gives the highest fractional iron absorption. Blood samples will be collected after dosing to measure isotope incorporation and calculate absorbed iron.
Who should consider this trial
Good fit: Ideal candidates are non-pregnant, non-lactating women with ferritin <45 µg/L, hemoglobin >120 g/L, BMI 18.5–24.9, body weight <70 kg, CRP <5 mg/L, no recent vitamin/mineral supplements, and no medical conditions or medications that affect iron metabolism.
Not a fit: People who are pregnant or breastfeeding, anemic, outside the BMI/weight limits, strict vegans, regular smokers, have GI or metabolic disorders affecting iron, or are taking supplements or medications that alter iron metabolism are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, encapsulated lactoferrin could increase iron uptake from food or supplements, allowing lower iron doses and fewer side effects for people with iron depletion.
How similar studies have performed: Previous clinical work has shown some benefits of lactoferrin for iron status, but protecting apo-lactoferrin from digestion via food-grade encapsulation to enhance iron absorption is a relatively new and not yet widely proven approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Serum ferritin \< 45 µg/L (iron depleted) * Body weight \< 70 kg * Body mass index 18,5 - 24,9 kg/m2 (normal weight) * Hemoglobin (Hb) \> 120 g/L (nonanemic) * C-reactive protein (CRP) \< 5 mg/L (no inflammation) Exclusion Criteria: * Pregnant or lactating * Strictly vegan * Cigarette smoking (\> 1 cigarette / week) * Gastrointestinal or metabolic disorders affecting iron absorption or metabolism * Use of medication known to affect iron metabolism (oral contraceptives are allowed) * Intake of vitamin and mineral supplements in the 2 weeks before study start and during the study * Blood transfusion, blood donation, or significant blood loss during the previous 4 months * once enrolled, inability to follow study procedures or major illness * Participation in another study with investigational drug within the 30 days preceding and during the present study
Where this trial is running
Zurich
- ETH Zurich, Laboratory of Clinical Biopharmacy — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Nicole Ursula Stoffel, Prof. — ETH Zurich
- Study coordinator: Salome Häcki, MSc
- Email: lobsterstudy@pharma.ethz.ch
- Phone: +41 44 632 75 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.