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

September 12, 2013 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Iron bioavailability from Stable isotopic labels
Time Frame: Up to 2 months
Up to 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood volume increase during exercise
Time Frame: Up to 2 months
Up to 2 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • EK 2012-N-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Generally Healthy

Clinical Trials on Exercise (Running)

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