Absorção de Ferro a partir de Lactoferrina Estabilizada: Um Estudo em Mulheres com Deficiência de Ferro (LOBSTER)
Absorção de Ferro a partir de Lactoferrina Estabilizada: Um Estudo Experimental em Mulheres com Deficiência de Ferro (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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Zurich, Suíça, 8092
- ETH Zurich, Laboratory of Clinical Biopharmacy
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Ferrous sulfate + inhibitory meal
4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal |
Maize porridge with labelled ferrous sulfate (58Fe) |
|
Comparador Ativo: 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 |
|
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 |
|
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) |
|
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) |
|
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) |
|
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) |
|
Comparador Ativo: Ferrous sulfate + water
100 mg of iron as ferrous sulfate + water |
Water with ferrous sulfate (labelled with iron isotope 58Fe) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fractional iron absorption (%)
Prazo: 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. |
Day 22
|
|
Fractional iron absorption (%)
Prazo: 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. |
Day 43
|
|
Fractional iron absorption (%)
Prazo: 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. |
Day 64
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hemoglobin (g/dL)
Prazo: Day 1
|
Iron status marker |
Day 1
|
|
Hemoglobin (g/dL)
Prazo: Day 22
|
Iron status marker |
Day 22
|
|
Hemoglobin (g/dL)
Prazo: Day 43
|
Iron status marker |
Day 43
|
|
Hemoglobin (g/dL)
Prazo: Day 64
|
Iron status marker |
Day 64
|
|
Serum Ferritin (µg/L)
Prazo: Day 1
|
Iron status marker |
Day 1
|
|
Serum Ferritin (µg/L)
Prazo: Day 22
|
Iron status marker |
Day 22
|
|
Serum Ferritin (µg/L)
Prazo: Day 43
|
Iron status marker |
Day 43
|
|
soluble Transferrin Receptor (mg/L)
Prazo: Day 1
|
Iron status marker |
Day 1
|
|
soluble Transferrin Receptor (mg/L)
Prazo: Day 22
|
Iron status marker |
Day 22
|
|
soluble Transferrin Receptor (mg/L)
Prazo: Day 43
|
Iron status marker |
Day 43
|
|
C-reactive protein (mg/L)
Prazo: Day 1
|
Chronic inflammation marker |
Day 1
|
|
C-reactive protein (mg/L)
Prazo: Day 22
|
Chronic inflammation marker |
Day 22
|
|
C-reactive protein (mg/L)
Prazo: Day 43
|
Chronic inflammation marker |
Day 43
|
|
Alpha-1-acid Glycoprotein (g/L)
Prazo: Day 1
|
Acute inflammation marker |
Day 1
|
|
Alpha-1-acid Glycoprotein (g/L)
Prazo: Day 22
|
Acute inflammation marker |
Day 22
|
|
Alpha-1-acid Glycoprotein (g/L)
Prazo: Day 43
|
Acute inflammation marker |
Day 43
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nicole Ursula Stoffel, Prof., ETH Zurich
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LOBSTER
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