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

9. Juni 2022 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

35

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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;

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: 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
Sonstiges: 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
Sonstiges: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fractional iron absorption
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hemoglobin (Hb)
Zeitfenster: Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
Serum ferritin (SF)
Zeitfenster: Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
Serum transferrin receptor (sTfR),
Zeitfenster: Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
C-reactive protein (CRP)
Zeitfenster: Screening (-14,) day 1 and day 19th
Inflammation status
Screening (-14,) day 1 and day 19th

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. April 2022

Primärer Abschluss (Tatsächlich)

20. Mai 2022

Studienabschluss (Tatsächlich)

20. Mai 2022

Studienanmeldedaten

Zuerst eingereicht

29. Oktober 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Februar 2022

Zuerst gepostet (Tatsächlich)

10. Februar 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2022

Zuletzt verifiziert

1. Juni 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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