Study of the Effects of Muscular Activity on Iron Metabolism

Not Applicable

• Conditions: Iron Overload; Iron Deficiency

• Registration Number: NCT00378469
• Lead Sponsor: Rennes University Hospital

Brief Summary

The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

Detailed Description

Hemojuvelin has been described as interfering with hepcidin, a key regulator of iron homeostasis. Hemojuvelin is mainly produced by muscle, and the relationship between exercise and iron metabolism can be questioned about.

The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will be investigated at two periods according to a cross-over design after:

1. 45 minutes of exercise on the ergocycle; and

2. no physical exercise.

Urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-19
• Study First Posted: 2006-09-20
• Status Verified: 2007-05
• Last Update Submitted: 2007-07-11
• Last Update Posted: 2007-07-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

• Male individuals aged between 18 and 40 years old
• Body mass index (BMI) between 18 and 25
• Normal at clinical examination
• Normal biological variables
• Written informed consent

Exclusion Criteria

• Mutation C282Y of the HFE gene
• Iron metabolism abnormality
• Inflammatory syndrome
• Chronic pathology or ongoing treatment
• Tobacco smoking, alcohol consuming more than 30g/day
• History of transfusion or blood-giving within 3 months
• Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of urinary hepcidin
Pharmacokinetics of blood hemojuvelin

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin

Trial Locations

Locations (2)

Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou; 🇫🇷 Rennes, France

Service des Maladies du Foie - Hôpital de Pontchaillou; 🇫🇷 Rennes, France