Bleeding Gastric, Constipation, Cramp, Abdominal, Diarrhea
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFeSC
Supplement
Sponsors
Lallemand Bio-Ingredients
University of Calgary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Recovery | 14 days | The Recovery-Stress Questionnaire (rating scale 0-6, where 0=never and 6= always) |
Countries
Canada
Outcome results
None listed