Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT06038656
Eligibility Criteria:
Inclusion Criteria:
1. Female athlete.
2. Train at least 6 hours per week at moderate to high intensity.
3. Having low to moderate iron stores.
4. Willingness to consume the study supplement GOS during the intervention period.
5. Willingness not to consume daily nutritional supplements containing \>20 mg iron and/or pre- or probiotics (excluding food and beverages containing live cultures such as yoghurt, raw milk and cheese) during the study.
6. Willingness to not take any iron-containing supplements two days before and during the iron absorption study days or vitamin C on the iron absorption study days.
Exclusion Criteria:
1. Haemoglobin \<11 g/dl.
2. Treated or self-reported chronic disease, malabsorptive or gastrointestinal disorders (e.g. irritable bowel syndrome, functional bloating).
3. Pregnancy or lactation.
4. Subjects who cannot be expected to comply with the study protocol.
5. Difficulty drawing blood due to poor quality veins.
6. Individuals that have a fear of needles or suffer from vaso-vagal episodes when exposed to blood.
7. Participants who plan to start or stop the use of contraceptives before or during study period.
8. Participants who are lactose intolerant.
9. Participants who donated blood in the past 4 months or plan to donate during the study period.
10. Participants who use chronic anti-inflammatory medication such as corticosteroids or non-steroidal anti-inflammatory medication (NSAIDS).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT06038656
Study Brief:
Protocol Section:
NCT06038656