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临床试验/NCT04458662
NCT04458662已完成不适用

Iron and Muscular Damage: FEmale Metabolism and Menstrual Cycle During Exercise

Universidad Politecnica de Madrid1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
Hepcidin

研究概览

简要总结

This project is an observational controlled randomized counterbalance study. One hundred and three physically active and healthy women were selected to participate in the IronFEMME Study, of which 57 were eumenorrheic, 30 were oral contraceptive users (OCP) and 16 were postmenopausal women. The project consisted on two sections carrying out at the same time: Iron metabolism (Study I) and Muscle damage (Study II). For the study I, the exercise protocol consisted on an interval running test (8 bouts of 3 min at 85% of the maximal aerobic speed), whereas the study II protocol was based on an eccentric-based resistance exercise protocol (10 sets of 10 repetitions of plate-loaded barbell parallel back squats at 60% of their 1RM with 2 min of rest between sets). In both studies, eumenorrheic participants were evaluated at three specific moments of the menstrual cycle: Early-follicular phase, late-follicular phase and mid-luteal phase; OCP performed the trial at two moments: Withdrawal phase and active pill phase. Lastly, postmenopausal women were tested only once, since their hormonal status does not fluctuate. The three-step method was used to verify the menstrual cycle phase: calendar counting, blood analyses confirmation and urine-based ovulation kits. Blood samples were obtained to measure sexual hormones (e.g., 17β-Estradiol, Progesterone), iron metabolism parameters (e.g., Hepcidin, Iron, Ferritin, Transferrin) and muscle damage related markers (e.g., Creatine Kinase, Myoglobin, Lactate Dehydrogenase).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants were required to meet the following criteria:
  • Healthy adult females between 18 and 40 years old for eumerroheic and oral contraceptive groups or under 60 years old for postmenopausal women.
  • Presenting with healthy iron parameters (serum ferritin >20μg/l, haemoglobin >115 μg/l and transferrin saturation >16%).
  • Performing endurance training between 5 and 12 h per week (study I) or experienced in resistance training performing at least 1 h session two times per week during a minimum of a year (study II).

排除标准

  • The exclusion criteria included:
  • Irregular menstrual cycles.
  • Any existing disease and/or metabolic or hormonal disorder.
  • Any musculoskeletal injury in the last six months prior to the beginning of the project.
  • Any surgery interventions (e.g. ovariectomy) or other medical conditions that would be exacerbated by an eccentric resistance exercise protocol.
  • Regular use of medication or dietary supplements that could affect the results (e.g. nonsteroidal anti-inflammatory drugs).
  • Taking medication that alters vascular function (e.g. tricyclic antidepressants, α-blockers, β-blockers, etc.).
  • Pregnancies in the year preceding.

结局指标

主要结局

Hepcidin

时间窗: 24 hours post-exercise

Hepcidin is a protein that in humans is encoded by the HAMP gene. Hepcidin is a key regulator of the entry of iron into the circulation in mammals

Creatine kinase

时间窗: 48 hours post-exercise

It is an enzyme that helps regulate the concentration of adenosine triphosphate within a cell. To do so, creatine kinase catalyzes the movement of a phosphate group from ATP to creatine, forming phosphocreatine. This molecules stores the phosphate group in a stable form, acting as an energy reservoir in cells.

次要结局

  • CRP(48 hours post-exercise)
  • Transferrin(24 hours post-exercise)
  • Iron(24 hours post-exercise)
  • LDH(48 hours post-exercise)
  • Ferritin(24 hours post-exercise)
  • Mioglobin(48 hours post-exercise)
  • TNF-alfa(48 hours post-exercise)
  • Interleukin-6(48 hours post-exercise)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ANA BELEN PEINADO LOZANO

Associate Professor

Universidad Politecnica de Madrid

研究点 (1)

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