CompletedNot Applicable

Exercise and Galactooligosaccharide Supplementation on Inflammation and Iron Absorption (FexerGOS)

South Africa22 participantsStarted 2024-03-01

Plain-language summary

Iron depletion is common in female athletes depending on the sports discipline. Endurance and resistance exercise can induce inflammation thereby reducing dietary iron absorption. Galacto-oligosaccharides (GOS) improved iron absorption in young healthy women and infants, and improved gut inflammation in iron-supplemented infants. A stable isotope study will be performed to investigate the effect exercise and acute and chronic GOS supplementation on inflammation and iron absorption in female athletes.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female athlete.
. Train at least 6 hours per week at moderate to high intensity.
. Having low to moderate iron stores.
. Willingness to consume the study supplement GOS during the intervention period.
. 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.
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

a. Fractional iron absorption (%)

Timeframe: Visit 8 (day 29) and 15 (day 92).

b. Fractional iron absorption (%)

Timeframe: Visit 8 (day 29) and 15 (day 92).

c. Fractional iron absorption (%)

Timeframe: Visit 8 (day 29) and 15 (day 92).

Trial details

NCT IDNCT06038656

SponsorNorth-West University, South Africa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-19

View on ClinicalTrials.gov More Resistance Exercise trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female athlete.
. Train at least 6 hours per week at moderate to high intensity.
. Having low to moderate iron stores.
. Willingness to consume the study supplement GOS during the intervention period.
. 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.
. 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.