Iron Deficiency (Without Anemia)
Conditions
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
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)
Maize porridge with sodium caseinate-lactoferrin-Fe (intrinsically labeled with iron isotope 54)
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
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Fractional iron absorption (%) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin (g/dL) | Day 1 | Iron status marker |
| Serum Ferritin (µg/L) | Day 1 | Iron status marker |
| soluble Transferrin Receptor (mg/L) | Day 1 | Iron status marker |
| C-reactive protein (mg/L) | Day 1 | Chronic inflammation marker |
| Alpha-1-acid Glycoprotein (g/L) | Day 1 | Acute inflammation marker |
Countries
Switzerland
Contacts
ETH Zurich