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Completed

NCT Number: NCT04458662

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

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).

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Behavior Exercise Induced Iron-deficiency Exercise Induced Muscle Damage Hematologic Diseases Hemic and Lymphatic Diseases Inflammation Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Regulation of Sex Hormones on Hepcidin Regulation of Sex Hormones on Muscle Damage

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Laboratorio de Fisiología Del Esfuerzo. Facultad de Ciencias de La Actividad Física Y Del Deporte. Universidad Politécnica de Madrid.

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.
  • Smoking.

Treatment and study plan

Interval running protocol / eccentric-based resistance exercise protocol

Procedure

Primary outcomes

  1. Hepcidin

    Time frame: pre-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

  2. Hepcidin

    Time frame: 0 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

  3. Hepcidin

    Time frame: 3 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

  4. Hepcidin

    Time frame: 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

  5. Creatine kinase

    Time frame: pre-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.

  6. Creatine kinase

    Time frame: 2 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.

  7. Creatine kinase

    Time frame: 24 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.

  8. Creatine kinase

    Time frame: 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.

Secondary outcomes

  1. Iron

    Time frame: pre-exercise

  2. Iron

    Time frame: 0 hours post-exercise

  3. Iron

    Time frame: 3 hours post-exercise

  4. Iron

    Time frame: 24 hours post-exercise

  5. Transferrin

    Time frame: pre-exercise

  6. Transferrin

    Time frame: 0 hours post-exercise

  7. Transferrin

    Time frame: 3 hours post-exercise

  8. Transferrin

    Time frame: 24 hours post-exercise

  9. Ferritin

    Time frame: pre-exercise

  10. Ferritin

    Time frame: 0 hours post-exercise

  11. Ferritin

    Time frame: 3 hours post-exercise

  12. Ferritin

    Time frame: 24 hours post-exercise

  13. Mioglobin

    Time frame: pre-exercise

  14. Mioglobin

    Time frame: 2 hours post-exercise

  15. Mioglobin

    Time frame: 24 hours post-exercise

  16. Mioglobin

    Time frame: 48 hours post-exercise

  17. LDH

    Time frame: pre-exercise

    Lactate deshidrogenase

  18. LDH

    Time frame: 2 hours post-exercise

    Lactate deshidrogenase

  19. LDH

    Time frame: 24 hours post-exercise

    Lactate deshidrogenase

  20. LDH

    Time frame: 48 hours post-exercise

    Lactate deshidrogenase

  21. TNF-alfa

    Time frame: pre-exercise

  22. TNF-alfa

    Time frame: 2 hours post-exercise

  23. TNF-alfa

    Time frame: 24 hours post-exercise

  24. TNF-alfa

    Time frame: 48 hours post-exercise

  25. Interleukin-6

    Time frame: pre-exercise

  26. Interleukin-6

    Time frame: 0 hours post-exercise

  27. Interleukin-6

    Time frame: 2 hours post-exercise

  28. Interleukin-6

    Time frame: 24 hours post-exercise

  29. Interleukin-6

    Time frame: 48 hours post-exercise

  30. CRP

    Time frame: pre-exercise

    C-reactive protein

  31. CRP

    Time frame: 0 hours post-exercise

    C-reactive protein

  32. CRP

    Time frame: 2 hours post-exercise

    C-reactive protein

  33. CRP

    Time frame: 24 hours post-exercise

    C-reactive protein

  34. CRP

    Time frame: 48 hours post-exercise

    C-reactive protein

Sponsors and collaborators

Lead sponsor

Universidad Politecnica de Madrid

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Acronym: IronFEMME

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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