Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07394972
NA

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

Sponsor: Nicole Stoffel

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-02-17

Completion Date

2026-05

Last Updated

2026-02-12

Healthy Volunteers

Yes

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)

Locations (1)

ETH Zurich, Laboratory of Clinical Biopharmacy

Zurich, Switzerland