The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01730521
First received: November 7, 2012
Last updated: September 12, 2013
Last verified: September 2013

November 7, 2012
September 12, 2013
October 2012
December 2012   (final data collection date for primary outcome measure)
Iron bioavailability from Stable isotopic labels [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01730521 on ClinicalTrials.gov Archive Site
Blood volume increase during exercise [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
Same as current
Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein) [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
Same as current
 
The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood and serum samples

Non-Probability Sample

Subjects studying or working at the University of Zürich or ETH Zürich

Generally Healthy
Behavioral: Exercise (Running)
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.
Difference in Iron bioavailabilty exercise and resting phase
the subjects will act as their own control during the study
Intervention: Behavioral: Exercise (Running)
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. Epub 2010 Oct 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2013
December 2012   (final data collection date for primary outcome measure)

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)
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01730521
EK 2012-N-27
No
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
Not Provided
Principal Investigator: Diego Moretti, PhD ETH Zürich
Swiss Federal Institute of Technology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP