Clinical trial NCT04458662: Iron and Muscular Damage: FEmale Metabolism and Menstrual Cycle During Exercise
Official title: Iron and Muscular Damage: FEmale Metabolism and Menstrual Cycle During Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-deficiency
Inflammation
Exercise Induced Iron-deficiency
Exercise Induced Muscle Damage
Regulation of Sex Hormones on Hepcidin
Regulation of Sex Hormones on Muscle Damage
Iron Metabolism Disorders
Keywords: Hepcidin
Iron deficiency
Menstrual cycle
Muscle damage
Creatine kinase
Female
Exercise
Estrogen
Progesterone
Oral contraceptives
Postmenopausal women
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2020-07-07
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physically active and healthy women. Study I, 37 eumenorrheic women (30.0±6.3 yrs; 59.8±15.7 kg; 163.7±6.3 cm): endurance training (ET) experience of 7.7 yrs and training volume of 5.5±0.9 h/week. Study II, 20 eumenorrheic women (28.8±6.2 yrs; 57.5±13.8 kg; 163.9±6.4 cm): strength training (ST) experience of 6.4±4.1 yrs and training volume of 7.5±2.1 h/week. Eumenorrheic women selected to participate in Study I and II were different, whereas oral contraceptive users and postmenopausal women participated in both studies. 30 oral contraceptive users (25.1±4.3 yrs; 56.2±10.9 kg; 163.1±5.5 cm): ET experience of 7.3±5.5 yrs and training volume of 3.4±1.5 h/week; ST experience of 3.1±1.9 yrs and training volume of 2.5±1.4 h/week. 16 postmenopausal women (51.4±3.7 yrs; 56.7±8.3 kg; 161.7±4.9 cm): ET experience of 7.9±3.4 yrs and training volume of 4.1±1.2 h/week; ST experience of 3.1±1.9 yrs and training volume of 1.6±0.9 h/week

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Hepcidin
timeFrame: pre-exercise
measure: Hepcidin
timeFrame: 0 hours post-exercise
measure: Hepcidin
timeFrame: 3 hours post-exercise
measure: Hepcidin
timeFrame: 24 hours post-exercise
measure: Creatine kinase
timeFrame: pre-exercise
measure: Creatine kinase
timeFrame: 2 hours post-exercise
measure: Creatine kinase
timeFrame: 24 hours post-exercise
measure: Creatine kinase
timeFrame: 48 hours post-exercise
Secondary outcomes:
measure: Iron
timeFrame: pre-exercise
measure: Iron
timeFrame: 0 hours post-exercise
measure: Iron
timeFrame: 3 hours post-exercise
measure: Iron
timeFrame: 24 hours post-exercise
measure: Transferrin
timeFrame: pre-exercise
measure: Transferrin
timeFrame: 0 hours post-exercise
measure: Transferrin
timeFrame: 3 hours post-exercise
measure: Transferrin
timeFrame: 24 hours post-exercise
measure: Ferritin
timeFrame: pre-exercise
measure: Ferritin
timeFrame: 0 hours post-exercise
measure: Ferritin
timeFrame: 3 hours post-exercise
measure: Ferritin
timeFrame: 24 hours post-exercise
measure: Mioglobin
timeFrame: pre-exercise
measure: Mioglobin
timeFrame: 2 hours post-exercise
measure: Mioglobin
timeFrame: 24 hours post-exercise
measure: Mioglobin
timeFrame: 48 hours post-exercise
measure: LDH
timeFrame: pre-exercise
measure: LDH
timeFrame: 2 hours post-exercise
measure: LDH
timeFrame: 24 hours post-exercise
measure: LDH
timeFrame: 48 hours post-exercise
measure: TNF-alfa
timeFrame: pre-exercise
measure: TNF-alfa
timeFrame: 2 hours post-exercise
measure: TNF-alfa
timeFrame: 24 hours post-exercise
measure: TNF-alfa
timeFrame: 48 hours post-exercise
measure: Interleukin-6
timeFrame: pre-exercise
measure: Interleukin-6
timeFrame: 0 hours post-exercise
measure: Interleukin-6
timeFrame: 2 hours post-exercise
measure: Interleukin-6
timeFrame: 24 hours post-exercise
measure: Interleukin-6
timeFrame: 48 hours post-exercise
measure: CRP
timeFrame: pre-exercise
measure: CRP
timeFrame: 0 hours post-exercise
measure: CRP
timeFrame: 2 hours post-exercise
measure: CRP
timeFrame: 24 hours post-exercise
measure: CRP
timeFrame: 48 hours post-exercise
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Laboratorio de Fisiología Del Esfuerzo. Facultad de Ciencias de La Actividad Física Y Del Deporte. Universidad Politécnica de Madrid.
Study officials:
affiliation: LFE Research Group. Universidad Politécnica de Madrid
name: Ana Belén Peinado
role: STUDY_DIRECTOR
References:
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citation: Romero-Parra N, Barba-Moreno L, Rael B, Alfaro-Magallanes VM, Cupeiro R, Diaz AE, Calderon FJ, Peinado AB. Influence of the Menstrual Cycle on Blood Markers of Muscle Damage and Inflammation Following Eccentric Exercise. Int J Environ Res Public Health. 2020 Mar 2;17(5):1618. doi: 10.3390/ijerph17051618.
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