A Novel Iron Supplement for Athletes: Phase I

University of Calgary14 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Constipation Diarrhea Cramp, Abdominal Bleeding Gastric

Interventions

FeSCDIETARY_SUPPLEMENT

Supplement

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Calgary

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

GI Symptoms

Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)

Time frame: Daily for 14 days

Gastrointestinal symptoms

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)

Time frame: Weekly for 14 days

Secondary Outcomes

Supplement Tolerability and Preferences Questionnaire

Consumer preferences compared to standard of care (rating scale 0-4, where 0=not at all and 4=very much)

Time frame: 14 days

Recovery

The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always)

Time frame: 14 days

Data from ClinicalTrials.gov

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