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A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II

Novel Iron-Based Supplement for Active Young Women With Sub-Optimal Iron

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06269913
Enrollment
30
Registered
2024-02-21
Start date
2024-06-17
Completion date
2025-12-31
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiencies

Keywords

iron, microbiota, endurance. exercise

Brief summary

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.

Detailed description

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.

Interventions

OTHERFeSC

Iron/yeast complex

Sponsors

Mitacs
CollaboratorINDUSTRY
Natural Sciences and Engineering Research Council, Canada
CollaboratorOTHER
University of Calgary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* cis-gendered female 18-25years old * sub-optimal iron status (ferritin ≤45mcg/ L) * At least 1 year past the age of menarche * Engage in moderate to vigorous endurance activity for at least 3 hours a week

Exclusion criteria

* Supplemented with iron iron (\>5mg/day), prebiotics, or probiotics in last 3 months * antibiotic use in last 3 months * \- Energy availability \>30 kcal/kg lean body mass

Design outcomes

Primary

MeasureTime frameDescription
Upper Gut Microbiome4 weeks, 8 weeksSIMBA capsule
Hemoglobin4 weeks, 8 weeksHemoglobin concentration
Iron Status4 weeks, 8 weeksFerritin
Lower Gut microbiome4 weeks, 8 weeksFecal sample

Secondary

MeasureTime frameDescription
Gastrointestinal Symptoms 1Weekly for 8 weeksGastrointestinal Symptoms Questionnaire
Exercise Capacity8 weeksOxygen Consumption (VO2max)
Hemoglobin Mass8 weeksCarbon monoxide Rebreathing Technique

Other

MeasureTime frameDescription
Gastrointestinal Symptoms 2Weekly for 8 weeksPatient-Reported Outcomes Measurement Information System
Stress and RecoveryWeekly for 8 weeksThe Recovery-Stress Questionnaire
SleepinessWeekly for 8 weeksEpworth Sleepiness scale

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026