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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Iron Deficiencies
• Intervention / Treatment: Other: FeSC

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4N1
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron/yeast complex (FeSC); Iron Supplement	Other: FeSC; Iron/yeast complex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron Status	Ferritin	4 weeks, 8 weeks
Hemoglobin	Hemoglobin concentration	4 weeks, 8 weeks
Upper Gut Microbiome	SIMBA capsule	4 weeks, 8 weeks
Lower Gut microbiome	Fecal sample	4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	Oxygen Consumption (VO2max)	8 weeks
Hemoglobin Mass	Carbon monoxide Rebreathing Technique	8 weeks
Gastrointestinal Symptoms 1	Gastrointestinal Symptoms Questionnaire	Weekly for 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleepiness	Epworth Sleepiness scale	Weekly for 8 weeks
Gastrointestinal Symptoms 2	Patient-Reported Outcomes Measurement Information System	Weekly for 8 weeks
Stress and Recovery	The Recovery-Stress Questionnaire	Weekly for 8 weeks

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Mitacs; Natural Sciences and Engineering Research Council, Canada
• Investigators: Principal Investigator: Jane Shearer, PhD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): March 12, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: microbiota; iron; endurance. exercise
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies
• Other Study ID Numbers: 23-0826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No