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OpenTrials
Active, Not Recruiting

NCT Number: NCT06269913

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N4N1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FeSC

Other

Iron/yeast complex

Primary outcomes

  1. Iron Status

    Time frame: 4 weeks, 8 weeks

    Ferritin

  2. Hemoglobin

    Time frame: 4 weeks, 8 weeks

    Hemoglobin concentration

  3. Upper Gut Microbiome

    Time frame: 4 weeks, 8 weeks

    SIMBA capsule

  4. Lower Gut microbiome

    Time frame: 4 weeks, 8 weeks

    Fecal sample

Secondary outcomes

  1. Exercise Capacity

    Time frame: 8 weeks

    Oxygen Consumption (VO2max)

  2. Hemoglobin Mass

    Time frame: 8 weeks

    Carbon monoxide Rebreathing Technique

  3. Gastrointestinal Symptoms 1

    Time frame: Weekly for 8 weeks

    Gastrointestinal Symptoms Questionnaire

Other outcomes

  1. Gastrointestinal Symptoms 2

    Time frame: Weekly for 8 weeks

    Patient-Reported Outcomes Measurement Information System

  2. Sleepiness

    Time frame: Weekly for 8 weeks

    Epworth Sleepiness scale

  3. Stress and Recovery

    Time frame: Weekly for 8 weeks

    The Recovery-Stress Questionnaire

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Mitacs
  • Natural Sciences and Engineering Research Council, Canada

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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