A Novel Iron Supplement for Athletes: Phase I

Not Applicable

Completed

• Conditions: Constipation; Bleeding Gastric; Diarrhea; Cramp, Abdominal
• Interventions: Dietary Supplement: FeSC

• Registration Number: NCT06285851
• Lead Sponsor: University of Calgary

Brief Summary

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.

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 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.

Study Timeline

• Study Start: 2023-11-23
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FeSC Cookie	FeSC	Iron-yeast complex

Primary Outcome Measures

Name	Time	Method
GI Symptoms	Daily for 14 days	Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)
Gastrointestinal symptoms	Weekly for 14 days	Patient-Reported Outcomes Measurement Information System (rating scale 0-4 where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much)

Secondary Outcome Measures

Name	Time	Method
Recovery	14 days	The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always)
Supplement Tolerability and Preferences Questionnaire	14 days	Consumer preferences compared to standard of care (rating scale 0-4, where 0=not at all and 4=very much)

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada