Effects of Iron Supplementation on Skeletal Muscle Properties in Females With Suboptimal Iron Storage

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity of Calgary

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Oral iron supplement
  • Placebo

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Calgary

Lead sponsor

Natural Sciences and Engineering Research Council, Canada

Collaborator