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Iron Deficiency (Without Anemia)LOBSTERNCT07394972

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

A study testing FeSO4 + meal-matrix, FeSO4 + native LF + meal-matrix and FeSO4 + NaCas-LF + meal-matrix in people with Iron Deficiency (Without Anemia), run by Nicole Stoffel at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Iron Deficiency (Without Anemia)
What is being tested?
FeSO4 + meal-matrix, FeSO4 + native LF + meal-matrix and FeSO4 + NaCas-LF + meal-matrix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSwitzerland
Study dates
2 Mar 2026to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • ETH Zurich, Laboratory of Clinical Biopharmacy

    Zurich, 8092

Other trials in Switzerland

About this study

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

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.

Being tested
FeSO4 + meal-matrix, FeSO4 + native LF + meal-matrix, FeSO4 + NaCas-LF + meal-matrix, NaCas-LF-Fe + meal-matrix, FeSO4 + LMP-LF + meal-matrix
Keywords
Lactoferrin, Iron Deficiency, Iron Absorption, Iron Fortification, Stable Iron Isotopes, Dietary Supplements, Iron Bioavailability
Medical subject headings
Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FeSO4 + meal-matrixOther

    Maize porridge with labelled ferrous sulfate (58Fe)

  • FeSO4 + native LF + meal-matrixOther

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

  • FeSO4 + NaCas-LF + meal-matrixOther

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

  • NaCas-LF-Fe + meal-matrixOther

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

  • FeSO4 + LMP-LF + meal-matrixOther

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

  • LMP-LF-Fe + meal-matrixOther

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

  • NaCas-LF-Fe + waterOther

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

  • LMP-LF-Fe + waterOther

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

  • FeSO4 + waterOther

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

Study groups in NCT07394972
Study groupRoleWhat they receive
Ferrous sulfate + inhibitory mealActive comparator4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal
Receives: Other: FeSO4 + meal-matrix
Ferrous sulfate + native LF + inhibitory mealActive comparator4 mg iron (58Fe) as ferrous sulfate + native LF + inhibitory meal
Receives: Other: FeSO4 + native LF + meal-matrix
Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory mealExperimental4 mg iron (57Fe) as ferrous sulfate + sodium caseinate-LF + inhibitory meal
Receives: Other: FeSO4 + NaCas-LF + meal-matrix
Encapsulated LF-Fe (Sodium caseinate) + inhibitory mealExperimental4 mg of iron (54Fe) encapsulated with LF in sodium caseinate + inhibitory meal
Receives: Other: NaCas-LF-Fe + meal-matrix
Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory mealExperimental4 mg of iron (54Fe) as ferrous sulfate + low methoxy pectin-LF + inhibitory meal
Receives: Other: FeSO4 + LMP-LF + meal-matrix
Encapsulated LF-Fe (low methoxy pectin) + inhibitory mealExperimental4 mg of iron (57Fe) encapsulated with LF in low methoxy pectin + inhibitory meal
Receives: Other: LMP-LF-Fe + meal-matrix
Encapsulated LF-Fe (sodium caseinate) + waterExperimental100 mg of iron encapsulated with LF in sodium caseinate + water
Receives: Other: NaCas-LF-Fe + water
Encapsulated LF-Fe (low methoxy pectin) + waterExperimental100 mg of iron encapsulated with LF in low methoxy pectin + water
Receives: Other: LMP-LF-Fe + water
Ferrous sulfate + waterActive comparator100 mg of iron as ferrous sulfate + water
Receives: Other: FeSO4 + water

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Day 64

Secondary outcomes (16)

  1. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 1

  2. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 22

  3. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 43

  4. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 64

  5. Serum Ferritin (µg/L)

    Iron status marker

    Measured: Day 1

  6. Serum Ferritin (µg/L)

    Iron status marker

    Measured: Day 22

  7. Serum Ferritin (µg/L)

    Iron status marker

    Measured: Day 43

  8. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Measured: Day 1

  9. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Measured: Day 22

  10. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Measured: Day 43

  11. C-reactive protein (mg/L)

    Chronic inflammation marker

    Measured: Day 1

  12. C-reactive protein (mg/L)

    Chronic inflammation marker

    Measured: Day 22

  13. C-reactive protein (mg/L)

    Chronic inflammation marker

    Measured: Day 43

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

    Acute inflammation marker

    Measured: Day 1

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

    Acute inflammation marker

    Measured: Day 22

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

    Acute inflammation marker

    Measured: Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start2 Mar 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394972
Sponsor's protocol ID
LOBSTER
Acronym
LOBSTER
Status last verified
Feb 2026
First submitted
31 Jan 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FeSO4 + meal-matrix, FeSO4 + native LF + meal-matrix and FeSO4 + NaCas-LF + meal-matrix in people with Iron Deficiency (Without Anemia), run by Nicole Stoffel at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fractional iron absorption (%) (time frame: Day 22). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07394972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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