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NCT Number: NCT07394972

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

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.

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Key information

Conditions

Iron Deficiency (Without Anemia) Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich, Laboratory of Clinical Biopharmacy

Zurich, 8092, Switzerland

Location status: Recruiting

Location contact

Salome Häcki, MSc

CONTACT

[email protected]

+41 44 632 75 78

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FeSO4 + meal-matrix

Other

Maize porridge with labelled ferrous sulfate (58Fe)

FeSO4 + native LF + meal-matrix

Other

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

FeSO4 + NaCas-LF + meal-matrix

Other

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

NaCas-LF-Fe + meal-matrix

Other

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

FeSO4 + LMP-LF + meal-matrix

Other

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

LMP-LF-Fe + meal-matrix

Other

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

NaCas-LF-Fe + water

Other

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

LMP-LF-Fe + water

Other

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

FeSO4 + water

Other

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

Primary outcomes

  1. Fractional iron absorption (%)

    Time frame: Day 22

    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.

  2. Fractional iron absorption (%)

    Time frame: Day 43

    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.

  3. Fractional iron absorption (%)

    Time frame: Day 64

    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

  1. Hemoglobin (g/dL)

    Time frame: Day 1

    Iron status marker

  2. Hemoglobin (g/dL)

    Time frame: Day 22

    Iron status marker

  3. Hemoglobin (g/dL)

    Time frame: Day 43

    Iron status marker

  4. Hemoglobin (g/dL)

    Time frame: Day 64

    Iron status marker

  5. Serum Ferritin (µg/L)

    Time frame: Day 1

    Iron status marker

  6. Serum Ferritin (µg/L)

    Time frame: Day 22

    Iron status marker

  7. Serum Ferritin (µg/L)

    Time frame: Day 43

    Iron status marker

  8. soluble Transferrin Receptor (mg/L)

    Time frame: Day 1

    Iron status marker

  9. soluble Transferrin Receptor (mg/L)

    Time frame: Day 22

    Iron status marker

  10. soluble Transferrin Receptor (mg/L)

    Time frame: Day 43

    Iron status marker

  11. C-reactive protein (mg/L)

    Time frame: Day 1

    Chronic inflammation marker

  12. C-reactive protein (mg/L)

    Time frame: Day 22

    Chronic inflammation marker

  13. C-reactive protein (mg/L)

    Time frame: Day 43

    Chronic inflammation marker

  14. Alpha-1-acid Glycoprotein (g/L)

    Time frame: Day 1

    Acute inflammation marker

  15. Alpha-1-acid Glycoprotein (g/L)

    Time frame: Day 22

    Acute inflammation marker

  16. Alpha-1-acid Glycoprotein (g/L)

    Time frame: Day 43

    Acute inflammation marker

Study contacts

Contact information is provided by the study sponsor or research team.

Salome Häcki, MSc

CONTACT

[email protected]

+41 44 632 75 78

Sponsors and collaborators

Lead sponsor

Nicole Stoffel

Other

Registry information

Official study title

Iron Absorption From Stabilized Lactoferrin: An Experimental Study in Iron Deficient Women (LOBSTER)

Acronym: LOBSTER

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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