- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01730521
The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation
Iron metabolism may undergo changes during exercise, with reductions in classical iron status markers due to a variety of postulated mechanism which include hemodilution, increased iron loss, hemolysis and increased iron storage in muscles. Furthermore, it has been reported that vigorous training increases hepcidin, a central regulatory peptide in iron metabolism. This increase has been ascribed to the presence of subclinical inflammation. Increased hepcidin levels may reduce iron bioavailability and iron incorporation in erythrocytes.
Twenty healthy men subjects will be recruited as subjects for this study. Subjects should be generally healthy, with no history of blood donation in the last 6 months, should weigh less than 85 Kg, and not take iron supplements and/or multivitamin supplements. Subjects should have familiarity to sports and running, but not currently (i.e. in the past 3 months) training for more than 1h per week on average.
The aim of this study is to measure an iron bioavailability during a resting and an exercise phase lasting approx. 14 days with training sessions on alternate days. Subjects will participate in both restign and exercising protocols and act as their own controls during the study. Iron bioavailability will be measured via the incorporation of stable isotopic labels 14 days after administration. To control for changes in blood volume during the course of the study, blood volume of the participating subjects will be measured before and after the exercise phase with the CO-rebreathing method.
Measurement of iron bioavailability and iron incorporation in a resting and exercising phase will allow determine if the increased level of hepcidin seen in in exercise will induce a lower iron bioavailability and iron incorporation during exercise.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Zürich, Suisse, 8092
- ETH Zurich
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- men, Generally Healthy age between 18-50 years;
- BMI between 18-25;
- nonanemic (Hb < 120 g/L);
- no intake of vitamins and nutritional supplements;
- no recent blood donation (<4 months);
- no previous participation in studies with stable iron isotopes in the past.
Exclusion Criteria:
- Chronic diseases, Metabolic diseases, GI tract diseases (self reported)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Difference in Iron bioavailabilty exercise and resting phase
the subjects will act as their own control during the study
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the study foresees a measurement of iron biavailability in a resting and in a exercising phase and subjects will act as their own control during the study.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Iron bioavailability from Stable isotopic labels
Délai: Up to 2 months
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Up to 2 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Blood volume increase during exercise
Délai: Up to 2 months
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Up to 2 months
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Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
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Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein)
Délai: Up to 2 months
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Up to 2 months
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Cercamondi CI, Egli IM, Ahouandjinou E, Dossa R, Zeder C, Salami L, Tjalsma H, Wiegerinck E, Tanno T, Hurrell RF, Hounhouigan J, Zimmermann MB. Afebrile Plasmodium falciparum parasitemia decreases absorption of fortification iron but does not affect systemic iron utilization: a double stable-isotope study in young Beninese women. Am J Clin Nutr. 2010 Dec;92(6):1385-92. doi: 10.3945/ajcn.2010.30051. Epub 2010 Oct 6. Erratum In: Am J Clin Nutr. 2015 Apr;101(4):894.
- Moretti D, Mettler S, Zeder C, Lundby C, Geurts-Moetspot A, Monnard A, Swinkels DW, Brittenham GM, Zimmermann MB. An intensified training schedule in recreational male runners is associated with increases in erythropoiesis and inflammation and a net reduction in plasma hepcidin. Am J Clin Nutr. 2018 Dec 1;108(6):1324-1333. doi: 10.1093/ajcn/nqy247.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- EK 2012-N-27
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