RecruitingNot ApplicableNCT07394972

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)


Sponsor

Nicole Stoffel

Enrollment

45 participants

Start Date

Feb 17, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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Interventions

OTHERFeSO4 + meal-matrix

Maize porridge with labelled ferrous sulfate (58Fe)

OTHERFeSO4 + native LF + meal-matrix

Maize porridge with labelled ferrous sulfate (58Fe) and lactoferrin

OTHERFeSO4 + NaCas-LF + meal-matrix

Maize porridge with labelled ferrous sulfate (57Fe) and in sodium caseinate encapsulated lactoferrin

OTHERNaCas-LF-Fe + meal-matrix

Maize porridge with sodium caseinate-lactoferrin-Fe (intrinsically labeled with iron isotope 54)

OTHERFeSO4 + LMP-LF + meal-matrix

Maize porridge with labelled ferrous sulfate (54Fe) and low methoxy pectin lactoferrin

OTHERLMP-LF-Fe + meal-matrix

Maize porridge with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57)

OTHERNaCas-LF-Fe + water

Water with sodium caseinate-lactoferrin-Fe (intrinsically labelled with iron isotope 54Fe)

OTHERLMP-LF-Fe + water

Water with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57Fe)

OTHERFeSO4 + water

Water with ferrous sulfate (labelled with iron isotope 58Fe)


Locations(1)

ETH Zurich, Laboratory of Clinical Biopharmacy

Zurich, Switzerland

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NCT07394972


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