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

Sponsor
Swiss Federal Institute of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT01730521
Collaborator
(none)
10
1
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Study Details

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 Phase
  • 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 :
Oct 1, 2012
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm 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 [Up to 2 months]

Secondary Outcome Measures

  1. Blood volume increase during exercise [Up to 2 months]

Other Outcome Measures

  1. Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein) [Up to 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 ETH Zürich Zürich Switzerland 8092

Sponsors and Collaborators

  • Swiss Federal Institute of Technology

Investigators

  • Principal Investigator: Diego Moretti, PhD, ETH Zürich

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Prof. Michael B. Zimmermann, Professor, MD, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01730521
Other Study ID Numbers:
  • EK 2012-N-27
First Posted:
Nov 21, 2012
Last Update Posted:
Sep 13, 2013
Last Verified:
Sep 1, 2013

Study Results

No Results Posted as of Sep 13, 2013