A Novel Iron-Based Supplement for Athletes Aged 14-17

Not Applicable

Active, not recruiting

• Conditions: Iron Deficiencies
• Interventions: Other: FeSC

• Registration Number: NCT06338787
• Lead Sponsor: University of Calgary

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, the investigators 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 endurance-trained adolescent females (aged 14-17) 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 which they will report feelings of stress and recovery as well as gastrointestinal symptoms.

Study Timeline

• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-01
• Study Start: 2024-06-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-03
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• cis-gendered female 14-18 years 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron/yeast complex (FeSC)	FeSC	Iron Supplement

Primary Outcome Measures

Name	Time	Method
Iron Status	Baseline, 4 weeks, 8 weeks	Ferritin
Hemoglobin	Baseline, 4 weeks, 8 weeks	Hemoglobin concentration
Lower Gut microbiome	Baseline, 4 weeks, 8 weeks	Fecal sample

Secondary Outcome Measures

Name	Time	Method
Exercise Capacity	Baseline, 4 weeks, 8 weeks	Oxygen Consumption (VO2max)

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada