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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous sulfate + inhibitory meal | Active Comparator | 4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal |
|
| Ferrous sulfate + native LF + inhibitory meal | Active Comparator | 4 mg iron (58Fe) as ferrous sulfate + native LF + inhibitory meal |
|
| Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory meal | Experimental | 4 mg iron (57Fe) as ferrous sulfate + sodium caseinate-LF + inhibitory meal |
|
| Encapsulated LF-Fe (Sodium caseinate) + inhibitory meal | Experimental | 4 mg of iron (54Fe) encapsulated with LF in sodium caseinate + inhibitory meal |
|
| Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory meal | Experimental | 4 mg of iron (54Fe) as ferrous sulfate + low methoxy pectin-LF + inhibitory meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FeSO4 + meal-matrix | Other | Maize porridge with labelled ferrous sulfate (58Fe) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin (g/dL) | Iron status marker | Day 1 |
| Hemoglobin (g/dL) | Iron status marker | Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salome Häcki, MSc | Contact | +41 44 632 75 78 | lobsterstudy@pharma.ethz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Ursula Stoffel, Prof. | ETH Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ETH Zurich, Laboratory of Clinical Biopharmacy | Recruiting | Zurich | 8092 | Switzerland |
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| Encapsulated LF-Fe (low methoxy pectin) + inhibitory meal |
| Experimental |
4 mg of iron (57Fe) encapsulated with LF in low methoxy pectin + inhibitory meal |
|
| Encapsulated LF-Fe (sodium caseinate) + water | Experimental | 100 mg of iron encapsulated with LF in sodium caseinate + water |
|
| Encapsulated LF-Fe (low methoxy pectin) + water | Experimental | 100 mg of iron encapsulated with LF in low methoxy pectin + water |
|
| Ferrous sulfate + water | Active Comparator | 100 mg of iron as ferrous sulfate + water |
|
| 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) |
|
| Hemoglobin (g/dL) | Iron status marker | Day 43 |
| Hemoglobin (g/dL) | Iron status marker | Day 64 |
| Serum Ferritin (µg/L) | Iron status marker | Day 1 |
| Serum Ferritin (µg/L) | Iron status marker | Day 22 |
| Serum Ferritin (µg/L) | Iron status marker | Day 43 |
| soluble Transferrin Receptor (mg/L) | Iron status marker | Day 1 |
| soluble Transferrin Receptor (mg/L) | Iron status marker | Day 22 |
| soluble Transferrin Receptor (mg/L) | Iron status marker | Day 43 |
| C-reactive protein (mg/L) | Chronic inflammation marker | Day 1 |
| C-reactive protein (mg/L) | Chronic inflammation marker | Day 22 |
| C-reactive protein (mg/L) | Chronic inflammation marker | Day 43 |
| Alpha-1-acid Glycoprotein (g/L) | Acute inflammation marker | Day 1 |
| Alpha-1-acid Glycoprotein (g/L) | Acute inflammation marker | Day 22 |
| Alpha-1-acid Glycoprotein (g/L) | Acute inflammation marker | Day 43 |
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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