Iron Absorption From Stabilized Lactoferrin: An Experimental Study in Iron Deficient Women (LOBSTER)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Lactoferrin (LF) is a natural iron-binding protein found in milk. It exists either in an iron-free state (apo-LF) or bound to iron (holo-LF). Whether LF binds iron to facilitate its absorption and/or to sequester iron from potential enteropathogens remains uncertain. However, while LF is a promising tool for treating iron deficiency, it is sensitive to heat during food processing and to the acidic environment of the human stomach. This degradation often causes LF to lose its functional properties before it can promote iron absorption effectively. This study aims to evaluate whether encapsulating apo-LF (either alone or in combination with iron) can protect LF from digestion and enhance iron absorption. Using a randomized, crossover design, different encapsulation methods will be compared to determine which results in the highest iron absorption in women with iron deficiency. All test compounds will be labeled with stable iron isotopes. Participants will consume the labeled compounds with a test meal or water in a randomized order, allowing for within subject comparisons. Fractional iron absorption will be measured 17 days after administration via the incorporation of labeled iron into red blood cells.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Switzerland
ETH Zurich, Laboratory of Clinical Biopharmacy
RECRUITING
Zurich
Contact Information
Primary
Salome Häcki, MSc
lobsterstudy@pharma.ethz.ch
+41 44 632 75 78
Time Frame
Start Date: 2026-02-17
Estimated Completion Date: 2026-05
Participants
Target number of participants: 45
Treatments
Active_comparator: Ferrous sulfate + inhibitory meal
4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal
Active_comparator: Ferrous sulfate + native LF + inhibitory meal
4 mg iron (58Fe) as ferrous sulfate + native LF + inhibitory meal
Experimental: Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory meal
4 mg iron (57Fe) as ferrous sulfate + sodium caseinate-LF + inhibitory meal
Experimental: Encapsulated LF-Fe (Sodium caseinate) + inhibitory meal
4 mg of iron (54Fe) encapsulated with LF in sodium caseinate + inhibitory meal
Experimental: Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory meal
4 mg of iron (54Fe) as ferrous sulfate + low methoxy pectin-LF + inhibitory meal
Experimental: Encapsulated LF-Fe (low methoxy pectin) + inhibitory meal
4 mg of iron (57Fe) encapsulated with LF in low methoxy pectin + inhibitory meal
Experimental: Encapsulated LF-Fe (sodium caseinate) + water
100 mg of iron encapsulated with LF in sodium caseinate + water
Experimental: Encapsulated LF-Fe (low methoxy pectin) + water
100 mg of iron encapsulated with LF in low methoxy pectin + water
Active_comparator: Ferrous sulfate + water
100 mg of iron as ferrous sulfate + water
Related Therapeutic Areas
Sponsors
Leads: Nicole Stoffel

This content was sourced from clinicaltrials.gov