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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
FeSO4 + meal-matrix
Other interventionMaize porridge with labelled ferrous sulfate (58Fe)
FeSO4 + native LF + meal-matrix
Other interventionMaize porridge with labelled ferrous sulfate (58Fe) and lactoferrin
FeSO4 + NaCas-LF + meal-matrix
Other interventionMaize porridge with labelled ferrous sulfate (57Fe) and in sodium caseinate encapsulated lactoferrin
NaCas-LF-Fe + meal-matrix
Other interventionMaize porridge with sodium caseinate-lactoferrin-Fe (intrinsically labeled with iron isotope 54)
FeSO4 + LMP-LF + meal-matrix
Other interventionMaize porridge with labelled ferrous sulfate (54Fe) and low methoxy pectin lactoferrin
LMP-LF-Fe + meal-matrix
Other interventionMaize porridge with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57)
NaCas-LF-Fe + water
Other interventionWater with sodium caseinate-lactoferrin-Fe (intrinsically labelled with iron isotope 54Fe)
LMP-LF-Fe + water
Other interventionWater with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57Fe)
FeSO4 + water
Other interventionWater with ferrous sulfate (labelled with iron isotope 58Fe)
Treatment groups
9
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
Hemoglobin (g/dL)
Iron status marker
Hemoglobin (g/dL)
Iron status marker
Hemoglobin (g/dL)
Iron status marker
Hemoglobin (g/dL)
Iron status marker
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nicole Stoffel
Lead sponsor
ETH Zurich
Sponsor institution