Assorbimento del Ferro da Lattoferrina Stabilizzata: Uno Studio su Donne con Carenza di Ferro (LOBSTER)
Assorbimento del Ferro dalla Lattoferrina Stabilizzata: Uno Studio Sperimentale in Donne Carenti di 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Zurich, Svizzera, 8092
- ETH Zurich, Laboratory of Clinical Biopharmacy
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Ferrous sulfate + inhibitory meal
4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal |
Maize porridge with labelled ferrous sulfate (58Fe) |
|
Comparatore attivo: 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 |
|
Sperimentale: 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 |
|
Sperimentale: 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) |
|
Sperimentale: 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 |
|
Sperimentale: 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) |
|
Sperimentale: 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) |
|
Sperimentale: 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) |
|
Comparatore attivo: Ferrous sulfate + water
100 mg of iron as ferrous sulfate + water |
Water with ferrous sulfate (labelled with iron isotope 58Fe) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fractional iron absorption (%)
Lasso di tempo: 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 (%)
Lasso di tempo: 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 (%)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hemoglobin (g/dL)
Lasso di tempo: Day 1
|
Iron status marker |
Day 1
|
|
Hemoglobin (g/dL)
Lasso di tempo: Day 22
|
Iron status marker |
Day 22
|
|
Hemoglobin (g/dL)
Lasso di tempo: Day 43
|
Iron status marker |
Day 43
|
|
Hemoglobin (g/dL)
Lasso di tempo: Day 64
|
Iron status marker |
Day 64
|
|
Serum Ferritin (µg/L)
Lasso di tempo: Day 1
|
Iron status marker |
Day 1
|
|
Serum Ferritin (µg/L)
Lasso di tempo: Day 22
|
Iron status marker |
Day 22
|
|
Serum Ferritin (µg/L)
Lasso di tempo: Day 43
|
Iron status marker |
Day 43
|
|
soluble Transferrin Receptor (mg/L)
Lasso di tempo: Day 1
|
Iron status marker |
Day 1
|
|
soluble Transferrin Receptor (mg/L)
Lasso di tempo: Day 22
|
Iron status marker |
Day 22
|
|
soluble Transferrin Receptor (mg/L)
Lasso di tempo: Day 43
|
Iron status marker |
Day 43
|
|
C-reactive protein (mg/L)
Lasso di tempo: Day 1
|
Chronic inflammation marker |
Day 1
|
|
C-reactive protein (mg/L)
Lasso di tempo: Day 22
|
Chronic inflammation marker |
Day 22
|
|
C-reactive protein (mg/L)
Lasso di tempo: Day 43
|
Chronic inflammation marker |
Day 43
|
|
Alpha-1-acid Glycoprotein (g/L)
Lasso di tempo: Day 1
|
Acute inflammation marker |
Day 1
|
|
Alpha-1-acid Glycoprotein (g/L)
Lasso di tempo: Day 22
|
Acute inflammation marker |
Day 22
|
|
Alpha-1-acid Glycoprotein (g/L)
Lasso di tempo: Day 43
|
Acute inflammation marker |
Day 43
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nicole Ursula Stoffel, Prof., ETH Zurich
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LOBSTER
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .