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

Not Applicable

Not yet recruiting

• Conditions: Iron Deficiencies
• Interventions: Other: FeSC

• Registration Number: NCT06269913
• 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, 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 Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26
• Study Start: 2024-05
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

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

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

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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

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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	4 weeks, 8 weeks	Ferritin
Hemoglobin	4 weeks, 8 weeks	Hemoglobin concentration
Upper Gut Microbiome	4 weeks, 8 weeks	SIMBA capsule
Lower Gut microbiome	4 weeks, 8 weeks	Fecal sample

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Mass	8 weeks	Carbon monoxide Rebreathing Technique
Exercise Capacity	8 weeks	Oxygen Consumption (VO2max)
Gastrointestinal Symptoms 1	Weekly for 8 weeks	Gastrointestinal Symptoms Questionnaire