Generally Healthy Clinical Trial
Official title:
The Effect of a Short Term Exercise Schedule on Oral Iron Bio-availability and Iron Incorporation
| Verified date | September 2013 |
| Source | Swiss Federal Institute of Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Laws and standards |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | June 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 50 Years |
| Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | ETH Zürich | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| Swiss Federal Institute of Technology |
Switzerland,
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. Erratum in: Am J Clin Nutr. 2015 Apr;101(4):894. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Hepcidin levels and inflammation markers (C-Reactive Protein, 1-Alpha acid glycoprotein) | Up to 2 months | No | |
| Primary | Iron bioavailability from Stable isotopic labels | Up to 2 months | No | |
| Secondary | Blood volume increase during exercise | Up to 2 months | No |