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OpenTrials
Completed

NCT Number: 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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

ETH Zürich

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise (Running)

Behavioral

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.

Primary outcomes

  1. Iron bioavailability from Stable isotopic labels

    Time frame: Up to 2 months

Secondary outcomes

  1. Blood volume increase during exercise

    Time frame: Up to 2 months

Other outcomes

  1. Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein)

    Time frame: Up to 2 months

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.