The goal of this clinical trial is to learn whether oral iron supplementation will increase skeletal muscle iron storage and its effects on exercise capacity in females with suboptimal iron status. The study will include healthy females, ages 18-40, who either have suboptimal or optimal iron stores.
The main questions it aims to answer are:
* Does iron supplementation increase skeletal muscle iron storage and alter the expression of iron-related and mitochondrial proteins? * Does iron supplementation improve single-leg exercise performance? * Is serum ferritin correlated with the abundance of iron-related proteins in skeletal muscle?
Researchers will compare outcomes from females with suboptimal iron status who receive oral iron supplementation to those who receive a placebo to see if supplementation improves muscle iron storage, protein expression, and exercise performance. Additionally, a non-intervention control group with optimal iron status will be included to assess baseline differences.
Participants will:
\- Be randomly assigned to receive 150 mg elemental iron or placebo (maltodextrin) every other day for 12 weeks
Complete pre- and post-supplementation testing, including:
* Blood draws to assess iron status * Skeletal muscle biopsies to analyze protein content * Whole-body and single-leg exercise tests to assess performance * Controls will undergo baseline-only testing to compare physiological and biochemical markers
biologically female
between the ages of 18-40 years of age at the time of enrolment
plasma ferritin ≤ 50 µg/ L (RCT) or >50 µg/L (controls)
complete Get Active Questionnaire (GAQ: Canadian Society for Exercise Physiology) without contraindication
have a body mass index (BMI) > 30 kg/m2
taking medications that have been shown to affect cardiovascular, respiratory, or metabolic responses to exercise (e.g., β-blockers, anti-inflammatories, anti-coagulants, insulin, etc.)
hemoglobin ≤ 120 g/L (anemia cut-off for women)
have known health problems or contraindications that prohibit exercise, including renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, arthritis, diabetes, respiratory disease, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions that are being treated and deemed likely to confound the results
Parallel
Oral iron supplement
Dietary supplementEncapsulated ferrous sulphate (150mg elemental iron)
Placebo
Other interventionEncapsulated polysaccharide (maltodextrin)
Muscle Ferritin
Muscle collection: The muscle biopsy involves the removal of a small piece of muscle tissue from the vastus lateralis using a sterile hollow needle. The area over the incision site will be carefully cleaned, and a small amount of local anesthetic will be injected into and under the skin. A small, 4 - 5 mm incision will be made in the skin to create an opening for the biopsy needle. The biopsy needle will then be inserted through the incision into the muscle, and a small piece of muscle (\~50 mg) will be removed, and the needle taken out. A medical doctor will perform this procedure. Protein analysis: Western blotting will be used to analyze the abundance of ferritin within small sections of the muscle sample.
Serum iron status
A forearm venous blood draw (10ml): Samples will be sent to a third-party laboratory for analysis of blood biomarkers, including ferritin and hemoglobin.
Iron-related proteins
Muscle collection: The muscle biopsy involves the removal of a small piece of muscle tissue from the vastus lateralis using a sterile hollow needle. The area over the incision site will be carefully cleaned, and a small amount of local anesthetic will be injected into and under the skin. A small, 4 - 5 mm incision will be made in the skin to create an opening for the biopsy needle. The biopsy needle will then be inserted through the incision into the muscle, and a small piece of muscle (\~50 mg) will be removed, and the needle taken out. A medical doctor will perform this procedure. Protein analysis: Small sections of each muscle sample will undergo Western blotting to analyze other iron-related proteins (e.g., transporters)
Mitochondrial proteins
Muscle collection: The muscle biopsy involves the removal of a small piece of muscle tissue from the vastus lateralis using a sterile hollow needle. The area over the incision site will be carefully cleaned, and a small amount of local anesthetic will be injected into and under the skin. A small, 4 - 5 mm incision will be made in the skin to create an opening for the biopsy needle. The biopsy needle will then be inserted through the incision into the muscle, and a small piece of muscle (\~50 mg) will be removed, and the needle taken out. A medical doctor will perform this procedure. Protein analysis: Small sections of each muscle sample will undergo Western blotting to analyze potential changes to mitochondrial protein content (e.g., transporters). Other sections of the same sample will undergo enzyme assays to quantify the relative changes in protein activity within the sample.
Whole body aerobic fitness (VO2max)
Exercise: Participants will complete an incremental ramp exercise test on a cycle ergometer (double-leg) to measure V̇O2max, serving to characterize participants' aerobic fitness. For this test, participants will cycle on a stationary bicycle while the resistance increases gradually until the participants are unable to continue because they are fatigued and/or wish to stop (\~10-20 min) Metabolic analysis: For whole-body exercise tests, participants will wear a face mask attached to a metabolic cart (Quark CPET, COSMED, Rome, Italy) that will analyze the volume and content of expired breath to determine oxygen uptake, carbon dioxide production, and minute ventilation. The maximal whole-body rate of oxygen consumption (V̇O2max) will be determined as the highest 30s average from a ramp incremental test.
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University of Calgary
Lead sponsor
Natural Sciences and Engineering Research Council, Canada
Collaborator
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