NCT01730521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

2 months

First QC Date

November 7, 2012

Last Update Submit

September 12, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Iron bioavailability from Stable isotopic labels

    Up to 2 months

Secondary Outcomes (1)

  • Blood volume increase during exercise

    Up to 2 months

Other Outcomes (1)

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

    Up to 2 months

Study Arms (1)

Difference in Iron bioavailabilty exercise and resting phase

the subjects will act as their own control during the study

Behavioral: Exercise (Running)

Interventions

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.

Difference in Iron bioavailabilty exercise and resting phase

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Chronic diseases, Metabolic diseases, GI tract diseases (self reported)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETH Zürich

Zurich, 8092, Switzerland

Location

Related Publications (2)

  • Cercamondi CI, Egli IM, Ahouandjinou E, Dossa R, Zeder C, Salami L, Tjalsma H, Wiegerinck E, Tanno T, Hurrell RF, Hounhouigan J, Zimmermann MB. Afebrile Plasmodium falciparum parasitemia decreases absorption of fortification iron but does not affect systemic iron utilization: a double stable-isotope study in young Beninese women. Am J Clin Nutr. 2010 Dec;92(6):1385-92. doi: 10.3945/ajcn.2010.30051. Epub 2010 Oct 6.

    PMID: 20926522BACKGROUND
  • Moretti D, Mettler S, Zeder C, Lundby C, Geurts-Moetspot A, Monnard A, Swinkels DW, Brittenham GM, Zimmermann MB. An intensified training schedule in recreational male runners is associated with increases in erythropoiesis and inflammation and a net reduction in plasma hepcidin. Am J Clin Nutr. 2018 Dec 1;108(6):1324-1333. doi: 10.1093/ajcn/nqy247.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum samples

MeSH Terms

Interventions

ExerciseRunning

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLocomotion

Study Officials

  • Diego Moretti, PhD

    ETH Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 21, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

September 13, 2013

Record last verified: 2013-09

Locations