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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiencies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iron/yeast complex (FeSC)

Iron Supplement

Group Type EXPERIMENTAL

FeSC

Intervention Type OTHER

Iron/yeast complex

Interventions

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FeSC

Iron/yeast complex

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes