A Novel Iron Supplement for Athletes: Phase I

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

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2023-12-12

Brief Summary

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Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance.

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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 tolerability of the developed supplement and any associated symptoms before conducting a clinical trial on this product. Participants will consume 40mg of elemental iron every second day for 14 days. Participants will complete a daily survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms. Additionally, participants will complete a more thorough survey of gastrointestinal symptoms at baseline, the mid-point, and the end of the study.

Conditions

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Constipation Diarrhea Cramp, Abdominal Bleeding Gastric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FeSC Cookie

Iron-yeast complex

Group Type EXPERIMENTAL

FeSC

Intervention Type DIETARY_SUPPLEMENT

Supplement

Interventions

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FeSC

Supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* cis-gendered female 18-25years old
* BMI \<25 kg/m2
* engaging in moderate to vigorous physical activity for ≥3 hours per week

Exclusion Criteria

* gastrointestinal issues (e.g. Irritable bowel disease/syndrome)
* chronic illnesses
* prescription medication (including oral contraceptives)
* allergies to supplement ingredients
* iron supplementation in the last 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes