NCT07394972

Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Nicole Stoffel · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron Deficiency (Without Anemia)

Interventions

Type	Name	Description
OTHER	FeSO4 + meal-matrix	Maize porridge with labelled ferrous sulfate (58Fe)
OTHER	FeSO4 + native LF + meal-matrix	Maize porridge with labelled ferrous sulfate (58Fe) and lactoferrin
OTHER	FeSO4 + NaCas-LF + meal-matrix	Maize porridge with labelled ferrous sulfate (57Fe) and in sodium caseinate encapsulated lactoferrin
OTHER	NaCas-LF-Fe + meal-matrix	Maize porridge with sodium caseinate-lactoferrin-Fe (intrinsically labeled with iron isotope 54)
OTHER	FeSO4 + LMP-LF + meal-matrix	Maize porridge with labelled ferrous sulfate (54Fe) and low methoxy pectin lactoferrin
OTHER	LMP-LF-Fe + meal-matrix	Maize porridge with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57)
OTHER	NaCas-LF-Fe + water	Water with sodium caseinate-lactoferrin-Fe (intrinsically labelled with iron isotope 54Fe)
OTHER	LMP-LF-Fe + water	Water with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57Fe)
OTHER	FeSO4 + water	Water with ferrous sulfate (labelled with iron isotope 58Fe)

Timeline

• Start date: 2026-02-17
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2026-02-06
• Last updated: 2026-02-12

Locations

1 site across 1 country: Switzerland