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

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

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)

Sponsors & Collaborators

• Nicole Stoffel

  lead OTHER

Principal Investigators

• Nicole Ursula Stoffel, Prof. · ETH Zurich

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-17

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• Switzerland

Study Locations