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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorNicole Stoffel

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Pregnant or lactating

Strictly vegan

Cigarette smoking (> 1 cigarette / week)

Gastrointestinal or metabolic disorders affecting iron absorption or metabolism

Trial design

Design model

Crossover

Treatments tested in this trial

  • FeSO4 + meal-matrix

    Other intervention

    Maize porridge with labelled ferrous sulfate (58Fe)

  • FeSO4 + native LF + meal-matrix

    Other intervention

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

  • FeSO4 + NaCas-LF + meal-matrix

    Other intervention

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

  • NaCas-LF-Fe + meal-matrix

    Other intervention

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

  • FeSO4 + LMP-LF + meal-matrix

    Other intervention

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

  • LMP-LF-Fe + meal-matrix

    Other intervention

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

  • NaCas-LF-Fe + water

    Other intervention

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

  • LMP-LF-Fe + water

    Other intervention

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

  • FeSO4 + water

    Other intervention

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

Treatment groups

45 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Ferrous sulfate + inhibitory mealActive comparator 1 intervention
Group B: Ferrous sulfate + native LF + inhibitory mealActive comparator 1 intervention
Group C: Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory mealExperimental treatment 1 intervention
Group D: Encapsulated LF-Fe (Sodium caseinate) + inhibitory mealExperimental treatment 1 intervention
Group E: Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory mealExperimental treatment 1 intervention
Group F: Encapsulated LF-Fe (low methoxy pectin) + inhibitory mealExperimental treatment 1 intervention
Group G: Encapsulated LF-Fe (sodium caseinate) + waterExperimental treatment 1 intervention
Group H: Encapsulated LF-Fe (low methoxy pectin) + waterExperimental treatment 1 intervention
Group I: Ferrous sulfate + waterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fractional iron absorption (%)

Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 17 days after intake compared to baseline.

Time frame
Day 22
2

Fractional iron absorption (%)

Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 17 days after intake compared to day 22.

Time frame
Day 43
3

Fractional iron absorption (%)

Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 17 days after intake compared to day 43.

Time frame
Day 64

Secondary outcomes

1

Hemoglobin (g/dL)

Iron status marker

Time frame
Day 1
2

Hemoglobin (g/dL)

Iron status marker

Time frame
Day 22
3

Hemoglobin (g/dL)

Iron status marker

Time frame
Day 43
4

Hemoglobin (g/dL)

Iron status marker

Time frame
Day 64

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicole Stoffel

Lead sponsor

ETH Zurich

Sponsor institution