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

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ClinicalTrials.gov Identifier: NCT01730521
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : September 13, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Generally Healthy Behavioral: Exercise (Running)

Study Design

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation
Study Start Date : October 2012
Primary Completion Date : December 2012
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Difference in Iron bioavailabilty exercise and resting phase
the subjects will act as their own control during the study
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.

Outcome Measures

Primary Outcome Measures :
  1. Iron bioavailability from Stable isotopic labels [ Time Frame: Up to 2 months ]

Secondary Outcome Measures :
  1. Blood volume increase during exercise [ Time Frame: Up to 2 months ]

Other Outcome Measures:
  1. Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein) [ Time Frame: Up to 2 months ]

Biospecimen Retention:   Samples With DNA
Whole blood and serum samples

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects studying or working at the University of Zürich or ETH Zürich

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730521

ETH Zürich
Zürich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
Principal Investigator: Diego Moretti, PhD University of Zurich
More Information

Additional Information:
Responsible Party: Prof. Michael B. Zimmermann, Professor, MD, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01730521     History of Changes
Other Study ID Numbers: EK 2012-N-27
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Trace Elements
Growth Substances
Physiological Effects of Drugs