About this trial
The goal of this clinical trial is to learn if different types and doses of oral iron supplements can improve iron levels, athletic performance, and gut health in young female athletes with low iron stores. The main questions it aims to answer are:
* Does a low dose of yeast-bound iron improve iron status better than traditional iron supplements? * Do the different iron supplements cause fewer or more gastrointestinal (stomach) symptoms? * How do iron supplements affect exercise performance and gut bacteria?
Researchers will compare three types of iron supplements:
* A low-dose iron supplement (40 mg) * A low-dose yeast-bound iron supplement (40 mg) * A high-dose iron supplement (150 mg)
This will help researchers find out which type of supplement is most effective and easiest on the stomach.
Participants will:
* Take one of the three assigned iron supplements every other day for 12 weeks * Complete fitness tests before and after the study, including cycling and jumping tests * Give blood samples to measure iron levels * Provide stool and intestinal samples to study gut bacteria * Swallow a SIMBA capsule before and after the study to collect a sample from the small intestine * Complete regular online surveys about sleep, stress, menstrual cycles, and gut symptoms
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Biologically female athlete
Age 16-35
At least one year past the age of menarche
Complete and pass the Get Active Questionnaire (GAQ)
Disqualifiers
Non-English speaking
Anemic (hemoglobin <120g/L)
Regular prebiotic (fiber) or probiotic use within 4 weeks of study enrollment
Current laxative use
Trial design
Parallel
Treatments tested in this trial
Low-dose iron (ferrous sulfate)
Dietary supplementEncapsulated low-dose ferrous sulphate (40mg elemental iron)
Yeast-bound iron (ferrous sulfate)
Dietary supplementEncapsulated yeast-bound low-dose ferrous sulphate (40mg elemental iron)
High-dose iron (ferrous sulfate)
Dietary supplementEncapsulated high-dose ferrous sulphate (150mg elemental iron)
Treatment groups
Trial outcomes
Primary outcomes
Iron status blood markers
A forearm venous blood draw
Iron status blood markers
A forearm venous blood draw
Iron status blood markers
A forearm venous blood draw
Iron status blood markers
A forearm venous blood draw
Secondary outcomes
VO2 Max
VO2 max testing on a cycling ergometer to assess peak power output, maximal oxygen consumption, and exercise thresholds. Individuals will begin with a 4-minute warm-up of low intensity, then proceed to a progressively increasing cycling challenge until they reach the point of voluntary exhaustion. Breath-by-breath measurement of gas exchange will be captured using open-circuit spirometry at rest, during exercise, and during recovery. Perceptual responses will be recorded during warm-up, every two minutes throughout exercise, and after task failure. Heart rate will be collected using a chest strap and measured throughout exercise. This method is used to evaluate the fitness levels of the participants. Metabolic cart measurements: Participants will wear a mask connected to a breath-by-breath metabolic cart to measure expired gases and minute ventilation. This equipment will continuously monitor the expired concentrations of O2 and CO2.
VO2 Max
VO2 max testing on a cycling ergometer to assess peak power output, maximal oxygen consumption, and exercise thresholds. Individuals will begin with a 4-minute warm-up of low intensity, then proceed to a progressively increasing cycling challenge until they reach the point of voluntary exhaustion. Breath-by-breath measurement of gas exchange will be captured using open-circuit spirometry at rest, during exercise, and during recovery. Perceptual responses will be recorded during warm-up, every two minutes throughout exercise, and after task failure. Heart rate will be collected using a chest strap and measured throughout exercise. This method is used to evaluate the fitness levels of the participants. Metabolic cart measurements: Participants will wear a mask connected to a breath-by-breath metabolic cart to measure expired gases and minute ventilation. This equipment will continuously monitor the expired concentrations of O2 and CO2.
Wingate
Wingate test completed on cycle ergometer to determine peak power output and fatigue index. During this test, participants will use a cycle ergometer. After a five-minute warm-up at low intensity, participants will pedal at maximum effort against a set resistance (7.5%) for 30 seconds, based on their body weight. Peak power will be assessed as well as other key performance metrics.
Wingate
Wingate test completed on cycle ergometer to determine peak power output and fatigue index. During this test, participants will use a cycle ergometer. After a five-minute warm-up at low intensity, participants will pedal at maximum effort against a set resistance (7.5%) for 30 seconds, based on their body weight. Peak power will be assessed as well as other key performance metrics.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
Mitacs
Collaborator
Natural Sciences and Engineering Research Council, Canada
Collaborator