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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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07394972
Acronym
LOBSTER
Enrollment
45
Registered
2026-02-06
Start date
2026-02-17
Completion date
2026-05-01
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency (Without Anemia)

Keywords

Lactoferrin, Iron Deficiency, Iron Absorption, Iron Fortification, Stable Iron Isotopes, Dietary Supplements, Iron Bioavailability

Brief 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.

Interventions

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)

OTHERNaCas-LF-Fe + meal-matrix

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

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

Sponsors

Nicole Stoffel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Fractional iron absorption (%)Day 22Fractional 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.

Secondary

MeasureTime frameDescription
Hemoglobin (g/dL)Day 1Iron status marker
Serum Ferritin (µg/L)Day 1Iron status marker
soluble Transferrin Receptor (mg/L)Day 1Iron status marker
C-reactive protein (mg/L)Day 1Chronic inflammation marker
Alpha-1-acid Glycoprotein (g/L)Day 1Acute inflammation marker

Countries

Switzerland

Contacts

CONTACTSalome Häcki, MSc
lobsterstudy@pharma.ethz.ch+41 44 632 75 78
PRINCIPAL_INVESTIGATORNicole Ursula Stoffel, Prof.

ETH Zurich

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026