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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
  Purpose

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 Intervention
Generally Healthy
Behavioral: Exercise (Running)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Iron bioavailability from Stable isotopic labels [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood volume increase during exercise [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein) [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood and serum samples


Enrollment: 10
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730521

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

Additional Information:
Publications:
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
Study First Received: November 7, 2012
Last Updated: September 12, 2013
Health Authority: Switzerland: Laws and standards

ClinicalTrials.gov processed this record on November 19, 2014