- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Zürich, Schweiz, 8092
- ETH Zurich
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Difference in Iron bioavailabilty exercise and resting phase
the subjects will act as their own control during the study
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Iron bioavailability from Stable isotopic labels
Tidsramme: Up to 2 months
|
Up to 2 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Blood volume increase during exercise
Tidsramme: Up to 2 months
|
Up to 2 months
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein)
Tidsramme: Up to 2 months
|
Up to 2 months
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- EK 2012-N-27
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