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| Name | Class |
|---|---|
| Lallemand Bio-Ingredients | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FeSC Cookie | Experimental | Iron-yeast complex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FeSC | Dietary Supplement | Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 14 days |
| Recovery | The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Shearer, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40817080 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 27, 2024 | |
| Reset | Sep 20, 2024 | |
| Release | Jun 11, 2026 | |
| Reset | Jul 7, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 27, 2024 | Sep 20, 2024 | |||
| Jun 11, 2026 |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D003967 | Diarrhea |
| D003085 | Colic |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
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| 14 days |
| Jul 7, 2026 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |