University of Calgary
Calgary, Alberta, T2N4N1, Canada
NCT Number: NCT06269913
Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.
This study is active but is not currently recruiting participants.
18 year–25 year
Female
Interventional
Not applicable
Calgary, Alberta, T2N4N1, Canada
Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, we have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in young, endurance-trained females with sub-optimal iron status. Participants will consume 40mg of elemental iron every second day for 8 weeks. Before and after supplementation,participants will be assessed for exercise capacity (VO2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Iron/yeast complex
Time frame: 4 weeks, 8 weeks
Ferritin
Time frame: 4 weeks, 8 weeks
Hemoglobin concentration
Time frame: 4 weeks, 8 weeks
SIMBA capsule
Time frame: 4 weeks, 8 weeks
Fecal sample
Time frame: 8 weeks
Oxygen Consumption (VO2max)
Time frame: 8 weeks
Carbon monoxide Rebreathing Technique
Time frame: Weekly for 8 weeks
Gastrointestinal Symptoms Questionnaire
Time frame: Weekly for 8 weeks
Patient-Reported Outcomes Measurement Information System
Time frame: Weekly for 8 weeks
Epworth Sleepiness scale
Time frame: Weekly for 8 weeks
The Recovery-Stress Questionnaire
University of Calgary
Other
Novel Iron-Based Supplement for Active Young Women With Sub-Optimal Iron
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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