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 range18 Years – 35 Years

SexFEMALE

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

✕. Haemoglobin \<11 g/dl.
✕. Treated or self-reported chronic disease, malabsorptive or gastrointestinal disorders (e.g. irritable bowel syndrome, functional bloating).
✕. Pregnancy or lactation.
✕. Subjects who cannot be expected to comply with the study protocol.
✕. Difficulty drawing blood due to poor quality veins.
✕. Individuals that have a fear of needles or suffer from vaso-vagal episodes when exposed to blood.
✕

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 range18 Years – 35 Years

SexFEMALE

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

✕. Haemoglobin \<11 g/dl.
✕. Treated or self-reported chronic disease, malabsorptive or gastrointestinal disorders (e.g. irritable bowel syndrome, functional bloating).
✕. Pregnancy or lactation.
✕. Subjects who cannot be expected to comply with the study protocol.
✕. Difficulty drawing blood due to poor quality veins.
✕. Individuals that have a fear of needles or suffer from vaso-vagal episodes when exposed to blood.
✕