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The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women (OTf)

9 giugno 2022 aggiornato da: Swiss Federal Institute of Technology

The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women With Non-anemic Iron Deficiency: Stable Isotope Study

OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism. Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants [19]. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women.

OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.

Panoramica dello studio

Descrizione dettagliata

Iron deficiency remains a major public health problem in both developed and developing countries. At present, iron deficiency is mostly combated with iron supplements in the form of iron salts, especially iron sulfate. Iron salts are absorbed via the nonhemic iron route via the DMT-1 receptor, the rate of absorption being 20% of the total iron content. The dietary supplement industry tries to counteract this problem and to supply the required amount of iron by increasing the iron concentration in the dietary supplements in order to compensate for the low absorption rate. However, the high dosage of iron leads to side effects. It would be more effective to maximize iron absorption rather than a high dose of iron. Chicken protein ovotransferrin (OTf) is recognized as an iron-binding protein and a member of the transferrin family. OTf has amino acid sequences that are identical to chicken serum transferrin and shows approximately 50% homology with mammalian transferrin and lactoferrin. Despite its iron binding properties and safety for human consumption, no studies have evaluated OTf as an enhancer of iron absorption in humans.

OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism.

Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . There are various studies that show the iron bioavailability of intrinsically labeled holo-Lf and apo- Lf and FeSO4. Lf appears to be a good source of bioavailable iron in both infants and in adults. Whether this is due to iron absorption through the Lf receptor and/or due to iron released from Lf joining the common non-heme iron pool and being subsequently absorbed, remains uncertain. The high affinity of OTf for iron (∼1030 M-1) at pH 7.5 implies that in presence of apo-OTf, iron will be sequestered. Lf also possesses the ability to bind iron (binding constants of ∼1022-1024 M-1) and retain it at lower pH. This difference in iron binding capacity, however, is not sufficient to establish conclusive statements regarding the activity of OTf in iron absorption.

It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women. Furthermore, despite its iron-binding properties and safety for human consumption, to the best of our knowledge, no studies have assessed OTf as an enhancer of iron absorption in humans. Therefore the use of OTf and Lf as iron absorption enhancers by comparing fractional iron absorption with that of FeSO4, the most commonly used iron supplement is investigated. This study will provide information regarding iron absorption enhancement, as well the behavior of OTf and Lf in adult women.

OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.

Participants are given OTf, Lf and iron sulfate solutions. To quantify this, stable iron isotopes are used as marker substances. Stable isotopes exist in nature and in our body and there are no risks associated with their ingestion. No changes in the iron status of the subjects are expected during the study.35 women of childbearing age are being recruited for the study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

35

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Zurich, Svizzera, 8092
        • ETH Zurich, Laboratory of Human Nutrition

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • female aged between 18-45 years old;
  • SF <25 µg / L;
  • BMI 18.5-24.9 kg / m2;
  • weight <70 kg;
  • signed informed consent;
  • Able to communicate and comprehend English language.

Exclusion Criteria:

  • Anemic (Hb <12 g / dL);
  • inflammation (CRP> 5 mg / L);
  • chronic digestive, renal and / or metabolic disease;
  • chronic medications (except for oral contraceptives);
  • use of vitamin, mineral and pre- and / or probiotic supplements in the previous 2 weeks and during the course of the study;
  • blood transfusion, blood donation or significant blood loss over the past 4 months;
  • difficulties with blood sampling;
  • antibiotic treatment in the previous 4 weeks before the start of the study and during the course of the study;
  • known hypersensitivity to egg;
  • pregnancy (tested in serum at screening) or intention to become pregnant during the course of the study;
  • lactation up to 6 weeks before study initiation;

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: OTf + FeSO4
OTf + FeSO4 - This is the experimental arm where Ferrous sulfate will be given to the participants along with apo-Ovotransferrin, a potential iron absorption enhancer. They will be given as solutions that will be spread on bread with butter and honey, a breakfast meal.
OTf (apo ovotransferrin) + FeSO4
Altro: Lf+ FeSO4
Lf + FeSO4 - This is the experimental arm where Ferrous sulfate will be given to the participants along with lactoferrin, a potential iron absorption enhancer. They will be given as solutions that will be spread on bread with butter and honey, a breakfast meal.
Lf (lactoferrin) + FeSO4
Altro: FeSO4
FeSO4 - This is the control arm where Ferrous sulfate will be given in the form of a solution that will be spread on bread with butter and honey, as a breakfast meal
Ferrous sulfate

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fractional iron absorption
Lasso di tempo: Day 19th of the study
The primary outcome is iron bioavailability (as measured by erythrocyte incorporation of the stable isotope labels) from the 2 different conditions in the standardized test meals.
Day 19th of the study

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hemoglobin (Hb)
Lasso di tempo: Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
Serum ferritin (SF)
Lasso di tempo: Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
Serum transferrin receptor (sTfR),
Lasso di tempo: Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
C-reactive protein (CRP)
Lasso di tempo: Screening (-14,) day 1 and day 19th
Inflammation status
Screening (-14,) day 1 and day 19th

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Jessica Rigutto-Farebrother, PhD, Laboratory of Human Nutrition ETH Zürich

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 aprile 2022

Completamento primario (Effettivo)

20 maggio 2022

Completamento dello studio (Effettivo)

20 maggio 2022

Date di iscrizione allo studio

Primo inviato

29 ottobre 2021

Primo inviato che soddisfa i criteri di controllo qualità

9 febbraio 2022

Primo Inserito (Effettivo)

10 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2022

Ultimo verificato

1 giugno 2022

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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