Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
LOBSTER
Iron Absorption From Stabilized Lactoferrin: An Experimental Study in Iron Deficient Women (LOBSTER)
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
February 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedFebruary 12, 2026
February 1, 2026
2 months
January 31, 2026
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 baseline.
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 22.
Day 43
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.
Day 64
Secondary Outcomes (16)
Hemoglobin (g/dL)
Day 1
Hemoglobin (g/dL)
Day 22
Hemoglobin (g/dL)
Day 43
Hemoglobin (g/dL)
Day 64
Serum Ferritin (µg/L)
Day 1
- +11 more secondary outcomes
Study Arms (9)
Ferrous sulfate + inhibitory meal
ACTIVE COMPARATOR4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal
Ferrous sulfate + native LF + inhibitory meal
ACTIVE COMPARATOR4 mg iron (58Fe) as ferrous sulfate + native LF + inhibitory meal
Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory meal
EXPERIMENTAL4 mg iron (57Fe) as ferrous sulfate + sodium caseinate-LF + inhibitory meal
Encapsulated LF-Fe (Sodium caseinate) + inhibitory meal
EXPERIMENTAL4 mg of iron (54Fe) encapsulated with LF in sodium caseinate + inhibitory meal
Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory meal
EXPERIMENTAL4 mg of iron (54Fe) as ferrous sulfate + low methoxy pectin-LF + inhibitory meal
Encapsulated LF-Fe (low methoxy pectin) + inhibitory meal
EXPERIMENTAL4 mg of iron (57Fe) encapsulated with LF in low methoxy pectin + inhibitory meal
Encapsulated LF-Fe (sodium caseinate) + water
EXPERIMENTAL100 mg of iron encapsulated with LF in sodium caseinate + water
Encapsulated LF-Fe (low methoxy pectin) + water
EXPERIMENTAL100 mg of iron encapsulated with LF in low methoxy pectin + water
Ferrous sulfate + water
ACTIVE COMPARATOR100 mg of iron as ferrous sulfate + water
Interventions
Maize porridge with labelled ferrous sulfate (58Fe)
Maize porridge with labelled ferrous sulfate (58Fe) and lactoferrin
Maize porridge with labelled ferrous sulfate (57Fe) and in sodium caseinate encapsulated lactoferrin
Maize porridge with sodium caseinate-lactoferrin-Fe (intrinsically labeled with iron isotope 54)
Maize porridge with labelled ferrous sulfate (54Fe) and low methoxy pectin lactoferrin
Maize porridge with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57)
Water with sodium caseinate-lactoferrin-Fe (intrinsically labelled with iron isotope 54Fe)
Water with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57Fe)
Water with ferrous sulfate (labelled with iron isotope 58Fe)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nicole Stoffellead
Study Sites (1)
ETH Zurich, Laboratory of Clinical Biopharmacy
Zurich, 8092, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Ursula Stoffel, Prof.
ETH Zurich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
January 31, 2026
First Posted
February 6, 2026
Study Start
February 17, 2026
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share