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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04458662
Acronym
IronFEMME
Enrollment
103
Registered
2020-07-07
Start date
2017-01-01
Completion date
2020-06-01
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Induced Iron-deficiency, Exercise Induced Muscle Damage, Inflammation, Iron-deficiency, Iron Metabolism Disorders, Regulation of Sex Hormones on Hepcidin, Regulation of Sex Hormones on Muscle Damage

Keywords

Hepcidin, Iron deficiency, Menstrual cycle, Muscle damage, Creatine kinase, Female, Exercise, Estrogen, Progesterone, Oral contraceptives, Postmenopausal women

Brief summary

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).

Interventions

PROCEDUREInterval running protocol / eccentric-based resistance exercise protocol

Sponsors

Ministerio de Economía y Competitividad, Spain
CollaboratorOTHER_GOV
Universidad Politecnica de Madrid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hepcidinpre-exerciseHepcidin 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 kinasepre-exerciseIt 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

MeasureTime frameDescription
Ferritinpre-exercise
Mioglobinpre-exercise
LDHpre-exerciseLactate deshidrogenase
Ironpre-exercise
Interleukin-6pre-exercise
CRPpre-exerciseC-reactive protein
TNF-alfapre-exercise
Transferrinpre-exercise

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026