A Novel Iron Supplement for Athletes: Phase I
Pilot Study for a Novel Iron-Based Supplement for Athletes
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2023
CompletedFirst Submitted
Initial submission to the registry
January 30, 2024
CompletedFirst Posted
Study publicly available on registry
February 29, 2024
CompletedMarch 28, 2024
March 1, 2024
19 days
January 30, 2024
March 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
GI Symptoms
Gastrointestinal Symptoms Questionnaire (rating scale 1-7 where 1= the absence of symptoms and 7=severe symptoms)
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)
Weekly for 14 days
Secondary Outcomes (2)
Supplement Tolerability and Preferences Questionnaire
14 days
Recovery
14 days
Study Arms (1)
FeSC Cookie
EXPERIMENTALIron-yeast complex
Interventions
Eligibility Criteria
You may qualify if:
- cis-gendered female 18-25years old
- BMI \<25 kg/m2
- engaging in moderate to vigorous physical activity for ≥3 hours per week
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Lallemand Bio-Ingredientscollaborator
Study Sites (1)
University of Calgary
Calgary, Alberta, Canada
Related Publications (1)
Shaw KA, Tompkins TA, Abrahamson-Durant B, MacNevin G, Parnell JA, MacInnis MJ, Reimer RA, Shearer J. Exploring tolerance and side effects of an innovative yeast-bound iron supplement: a feasibility trial. Pilot Feasibility Stud. 2025 Aug 15;11(1):110. doi: 10.1186/s40814-025-01690-w.
PMID: 40817080DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Shearer, PhD
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 30, 2024
First Posted
February 29, 2024
Study Start
November 23, 2023
Primary Completion
December 12, 2023
Study Completion
December 12, 2023
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share