Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Pharmacokinetics of urinary hepcidin
研究概览
简要总结
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.
详细描述
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:
- 45 minutes of exercise on the ergocycle; and
- no physical exercise.
Urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Pharmacokinetics of urinary hepcidin
Pharmacokinetics of blood hemojuvelin
次要结局
- Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin