Absorción de Hierro a partir de Lactoferrina Estabilizada: Un Estudio en Mujeres con Deficiencia de Hierro (LOBSTER)
Absorción de Hierro a partir de Lactoferrina Estabilizada: Un Estudio Experimental en Mujeres con Deficiencia de Hierro (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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Zurich, Suiza, 8092
- ETH Zurich, Laboratory of Clinical Biopharmacy
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Ferrous sulfate + inhibitory meal
4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal |
Maize porridge with labelled ferrous sulfate (58Fe) |
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Comparador activo: Ferrous sulfate + native LF + inhibitory meal
4 mg iron (58Fe) as ferrous sulfate + native LF + inhibitory meal |
Maize porridge with labelled ferrous sulfate (58Fe) and lactoferrin |
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Experimental: Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory meal
4 mg iron (57Fe) as ferrous sulfate + sodium caseinate-LF + inhibitory meal |
Maize porridge with labelled ferrous sulfate (57Fe) and in sodium caseinate encapsulated lactoferrin |
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Experimental: Encapsulated LF-Fe (Sodium caseinate) + inhibitory meal
4 mg of iron (54Fe) encapsulated with LF in sodium caseinate + inhibitory meal |
Maize porridge with sodium caseinate-lactoferrin-Fe (intrinsically labeled with iron isotope 54) |
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Experimental: Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory meal
4 mg of iron (54Fe) as ferrous sulfate + low methoxy pectin-LF + inhibitory meal |
Maize porridge with labelled ferrous sulfate (54Fe) and low methoxy pectin lactoferrin |
|
Experimental: Encapsulated LF-Fe (low methoxy pectin) + inhibitory meal
4 mg of iron (57Fe) encapsulated with LF in low methoxy pectin + inhibitory meal |
Maize porridge with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57) |
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Experimental: Encapsulated LF-Fe (sodium caseinate) + water
100 mg of iron encapsulated with LF in sodium caseinate + water |
Water with sodium caseinate-lactoferrin-Fe (intrinsically labelled with iron isotope 54Fe) |
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Experimental: Encapsulated LF-Fe (low methoxy pectin) + water
100 mg of iron encapsulated with LF in low methoxy pectin + water |
Water with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57Fe) |
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Comparador activo: Ferrous sulfate + water
100 mg of iron as ferrous sulfate + water |
Water with ferrous sulfate (labelled with iron isotope 58Fe) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fractional iron absorption (%)
Periodo de tiempo: Day 22
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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
|
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Fractional iron absorption (%)
Periodo de tiempo: Day 43
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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
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Fractional iron absorption (%)
Periodo de tiempo: Day 64
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hemoglobin (g/dL)
Periodo de tiempo: Day 1
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Iron status marker |
Day 1
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Hemoglobin (g/dL)
Periodo de tiempo: Day 22
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Iron status marker |
Day 22
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Hemoglobin (g/dL)
Periodo de tiempo: Day 43
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Iron status marker |
Day 43
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Hemoglobin (g/dL)
Periodo de tiempo: Day 64
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Iron status marker |
Day 64
|
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Serum Ferritin (µg/L)
Periodo de tiempo: Day 1
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Iron status marker |
Day 1
|
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Serum Ferritin (µg/L)
Periodo de tiempo: Day 22
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Iron status marker |
Day 22
|
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Serum Ferritin (µg/L)
Periodo de tiempo: Day 43
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Iron status marker |
Day 43
|
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soluble Transferrin Receptor (mg/L)
Periodo de tiempo: Day 1
|
Iron status marker |
Day 1
|
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soluble Transferrin Receptor (mg/L)
Periodo de tiempo: Day 22
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Iron status marker |
Day 22
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soluble Transferrin Receptor (mg/L)
Periodo de tiempo: Day 43
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Iron status marker |
Day 43
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C-reactive protein (mg/L)
Periodo de tiempo: Day 1
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Chronic inflammation marker |
Day 1
|
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C-reactive protein (mg/L)
Periodo de tiempo: Day 22
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Chronic inflammation marker |
Day 22
|
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C-reactive protein (mg/L)
Periodo de tiempo: Day 43
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Chronic inflammation marker |
Day 43
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Alpha-1-acid Glycoprotein (g/L)
Periodo de tiempo: Day 1
|
Acute inflammation marker |
Day 1
|
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Alpha-1-acid Glycoprotein (g/L)
Periodo de tiempo: Day 22
|
Acute inflammation marker |
Day 22
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Alpha-1-acid Glycoprotein (g/L)
Periodo de tiempo: Day 43
|
Acute inflammation marker |
Day 43
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nicole Ursula Stoffel, Prof., ETH Zurich
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LOBSTER
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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