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Study of the Effects of Muscular Activity on Iron Metabolism

NCT ID: NCT00378469

Last Updated: 2007-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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Iron Overload Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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45 minute exercise on ergocycle

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Pierre Brissot, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Bruno Laviolle, MD

Role: STUDY_CHAIR

Rennes University Hospital

Locations

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Service des Maladies du Foie - Hôpital de Pontchaillou

Rennes, , France

Site Status RECRUITING

Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Brissot, MD

Role: CONTACT

[email protected]
33-2-9928-4297

Fabrice Lainé, MD

Role: CONTACT

[email protected]
33-2-9928-3715

Facility Contacts

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Pierre Brissot, MD

Role: primary

[email protected]
33-2-9928-4297

Pierre Rochcongar, MD

Role: primary

[email protected]
33-2-9928-9323

Other Identifiers

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LOC/05-07

Identifier Type: -

Identifier Source: secondary_id

CIC0203/061

Identifier Type: -

Identifier Source: secondary_id

DGS 2006/0415

Identifier Type: -

Identifier Source: org_study_id