AzTrials
AzTrials

Resistance ExerciseFexerGOSNCT06038656

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

A study testing Galactooligosaccharides (GOS) in people with Resistance Exercise, run by North-West University, South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Resistance Exercise
What is being tested?
Galactooligosaccharides (GOS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSouth Africa
Study dates
1 Mar 2024to 25 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • Participants who plan to start or stop the use of contraceptives before or during study period.
  • Participants who are lactose intolerant.
  • Participants who donated blood in the past 4 months or plan to donate during the study period.
  • Participants who use chronic anti-inflammatory medication such as corticosteroids or non-steroidal anti-inflammatory medication (NSAIDS).

Trial locations and contacts

1 site in 1 country.

South Africa1 site
  • Este Vorster Research Facility

    Potchefstroom, North West, 2531

Other trials in South Africa

About this study

Official title: Effects of Exercise and Acute and Chronic Galactooligosaccharide Supplementation on Inflammation and Iron Absorption in Female Athletes

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.

Read the detailed description

Iron depletion is common in athletes, particularly in females, reaching prevalence rates up to 70% depending on the sports discipline. As iron is essential for energy production and oxygen transport, a deficiency can impair performance, especially in endurance athletes. Iron deficiency in athletes may be caused by inadequate intake, but reduced iron absorption and increased losses also seem to play a role. Both endurance and resistance exercise at a high intensity, can induce inflammation resulting in a hepcidin response via interleukin-6 (IL-6) regulation. Hepcidin is the master regulator of systemic iron homeostasis, and a recent study in adult males showed that vigorous exercise decreases dietary iron absorption associated with increases in IL-6 and hepcidin. Iron losses induced by exercise have been attributed to several factors, including gastrointestinal bleeding associated with endothelial damage, haematuria, haemolysis, and increased sweating. Galacto-oligosaccharides (GOS) have been shown to acutely enhance iron absorption in young, healthy women. In Kenyan infants with a high infectious disease burden, chronic GOS administration improved iron absorption and mitigated the negative effects of iron supplementation on gut inflammation, likely mediated by its bifidogenic effect. Whether GOS has the potential of improving iron absorption has not been studied in athletes.

The study aims are to determine 1) the effects of a bout of resistance exercise at 70% 1 repetition maximum (RM) on inflammation, hepcidin and iron absorption in female team athletes; and 2) the effect of acute and chronic GOS supplementation on iron absorption in response to the exercise bout.

The trial will entail two series of three iron absorption conditions separated by six weeks of GOS supplementation (10 g/day). The study participants will be 22 female athletes recruited from the North-West University and Potchefstroom area, South Africa. At baseline, the first series of three iron absorption studies will be conducted, all measuring iron absorption from a supplement administered with labelled ferrous fumarate in the following conditions: 1) after a period of rest; 2) three hours after an acute resistance exercise bout; and 3) three hours after an acute resistance exercise bout, co-administered with GOS. Following this, participants will consume GOS daily for 6 weeks, followed by an identical series of iron absorption studies. Markers of systemic and gut inflammation, hepcidin, microflora composition and iron status indicators before and after the GOS intervention will be determined. In addition, erythrocyte iron incorporation will be determined after both series of isotope studies. Furthermore, the kinetics of isotope appearance, inflammatory markers, and hepcidin for 24 hours during each of the six iron absorption studies will be investigated.

The primary hypotheses are that fractional iron absorption from a supplemental dose of ferrous fumarate will be: 1) lower three hours post exercise than post resting period; 2) higher with co-administration of GOS than without, both before and after six-week GOS intervention; and 3) higher after six-week intervention with GOS compared to baseline.

The secondary hypotheses are: 1) acute exercise bout will result in increased inflammatory and hepcidin response before and after intervention with GOS but the intervention may mediate these two responses; 2) chronic GOS intervention will increase relative abundance of Bifidobacterium spp, reduce gut inflammation and improve gut integrity and gut health; 3) chronic GOS intervention will improve iron status.

Being tested
Galactooligosaccharides (GOS)
Keywords
Galacto-oligosaccharides, female athletes, iron absorption, inflammation
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Galactooligosaccharides (GOS)Dietary supplement

    10 g of GOS provided as 14 g of powder will be consumed after mixing it in water or yoghurt.

    The absorption study test drinks administered during the 3 test conditions will be comprised as follows:

    Post rest period - 50 mg of iron as ferrous fumarate (Fefum) supplement, 6 mg 54Fe as Fefum and 300 ml of water with sucrose and lactose.

    Post exercise bout - 50 mg of iron as Fefum, 6 mg 58Fe as Fefum and 300 ml of water with sucrose and lactose.

    Post exercise bout co-administered with GOS - 50 mg of iron as Fefum, 6 mg 57Fe as Fefum and 300 ml of water with 10 g GOS.

Study groups in NCT06038656
Study groupRoleWhat they receive
ExperimentalExperimentalParticipants will receive 10 g of GOS daily for 6 weeks. Fractional iron absorption will be determined pre- and post the 6-week intervention from 3 conditions: 1) after a period of rest; 2) three hours after an acute resistance exercise bout without GOS and 3) three hours after an acute resistance exercise bout, co-administered with 10 g GOS.
Receives: Dietary Supplement: Galactooligosaccharides (GOS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. a. Fractional iron absorption (%)

    Fractional iron absorption will be measured at rest and after an exercise bout.

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

  2. b. Fractional iron absorption (%)

    Fractional iron absorption will be measured after an exercise bout with and without co-administration of GOS.

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

  3. c. Fractional iron absorption (%)

    Fractional iron absorption will be measured at rest and after an exercise bout before and after a 6-week intervention with GOS.

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

Secondary outcomes (28)
  1. Interleukin 6 (pg/mL)

    Interleukin 6 (IL-6) will be measured over 24 hours after rest and after exercise as a marker of exercise-induced inflammation.

    Measured: Visits 2 (day 1), 3 (day 2), 4 (day 8), 5 (day 9), 6 (day 15), 7 (day 16), 9 (day 64), 10 (day 65), 11 (day 71), 12 (day 72), 13 (day 78) and 14 (day 79)

  2. C-reactive protein (mg/L)

    C-reactive protein (CRP) will be measured in plasma to detect the presence of acute inflammation.

    Measured: Visits 2 (day 1), 4 (day 8), 6 (day 15), 9 (day 64), 11 (day 71) and 13 (day 78).

  3. Alpha-1-acid glycoprotein (g/L)

    Alpha-1-acid glycoprotein (AGP) will be measured in plasma to determine the presence of chronic inflammation.

    Measured: Visits 2 (day 1), 4 (day 8), 6 (day 15), 9 (day 64), 11 (day 71) and 13 (day 78).

  4. Hepcidin (ng/mL)

    Hepcidin, a major regulator of iron absorption and influenced by exercise-induced inflammation, will be measured in plasma over 24 hours.

    Measured: Visits 2 (day 1), 3 (day 2), 4 (day 8), 5 (day 9), 6 (day 15), 7 (day 16), 9 (day 64), 10 (day 65), 11 (day 71), 12 (day 72), 13 (day 78) and 14 (day 79)

  5. Lipid mediators (pg/µL )

    The following lipid mediators will be measured over 24 hours in plasma in response to exercise-induced inflammation:17-hydroxydocosahexaenoicacid (17-HDHA); 5-, 8-, 9-, 11-, 12-, 15 and 18- hydroxyeicosapentaenoicacid (HEPE); 5-, 8-, 11-, 12- and 15-hydroxyeicosatetraenoicacid (HETE); prostaglandin (PG) E2 and D2, and resolvin (Rv) D1 and E1).

    Measured: Visits 2 (day 1), 3 (day 2), 4 (day 8), 5 (day 9), 6 (day 15), 7 (day 16), 9 (day 64), 10 (day 65), 11 (day 71), 12 (day 72), 13 (day 78) and 14 (day 79)

  6. Erythropoietin (mIU/mL)

    Plasma erythropoietin, a marker of erythropoiesis, will be measured before and after period of rest and exercise.

    Measured: Visits 2 (day 1), 4 (day 8), 6 (day 15), 9 (day 64), 11 (day 71) and 13 (day 78).

  7. Serum iron isotope (%)

    Kinetics of serum iron isotope appearance during a period of rest and post-exercise, before and after intervention with GOS, and with and without co-administration of GOS.

    Measured: Visits 2 (day 1), 3 (day 2), 4 (day 8), 5 (day 9), 6 (day 15), 7 (day 16), 9 (day 64), 10 (day 65), 11 (day 71), 12 (day 72), 13 (day 78) and 14 (day 79).

  8. Gut microbial composition

    Gut microbiota profile will be assessed at baseline and endpoint.

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

  9. Faecal short chain fatty acids (µmol/g)

    Concentration of short chain fatty acids - acetate, propionate, isobutyrate, butyrate, formate, isovalerate will be measured in faecal samples before and after the 6-week intervention with GOS.

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

  10. Faecal pH

    Faecal pH will be measured at baseline and endpoint to determine a response to the GOS intervention.

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

  11. Faecal calprotectin (µg/g)

    Faecal calprotectin will be measured at baseline and endpoint as a marker of gut inflammation.

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

  12. Faecal zonulin (ng/mL)

    Faecal zonulin will be measured at baseline and endpoint as a marker of the integrity of the intestinal mucosal barrier.

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

  13. Intestinal fatty acid-binding protein (pg/mL)

    Intestinal fatty acid-binding protein (I-FABP), a marker of intestinal damage, will be measured in plasma at baseline and endpoint.

    Measured: Screening, Visits 4 (day 8), 8 (day 29), 9 (day 64), 11 (day 71) and 15 (day 92).

  14. Haemoglobin (g/dL)

    Haemoglobin will be measured in whole blood to determine presence of anaemia and for calculation of fractional iron absorption.

    Measured: Screening,Visit 8 (day 29), 9 (day 64) and 15 (day 92).

  15. Ferritin (µg/L)

    Ferritin will be measured in plasma to determine the presence of iron deficiency.

    Measured: Screening, Visits 2 (day 1) and 9 (day 64).

  16. Soluble transferrin receptor (mg/L)

    Soluble transferrin receptor (sTfR) will be measured in plasma to determine the presence of iron deficiency.

    Measured: Screening, Visits 2 (day 1) and 9 (day 64).

  17. Retinol-binding protein 4 (µmol/L)

    Retinol-binding protein 4 (RBP4) will be measured in plasma as a marker of vitamin A status.

    Measured: Screening, Visits 2 (day 1) and 9 (day 64).

  18. Thyroglobulin (µg/L)

    Thyroglobulin will be measured in plasma as a marker of iodine status.

    Measured: Screening, Visits 2 (day 1) and 9 (day 64).

  19. Fibroblast growth factor 21 (pg/mL)

    Fibroblast growth factor 21 (FGF-21) will be measured in plasma as a marker of environmental enteric dysfunction (EED).

    Measured: Screening,Visits 2 (day 1) and 9 (day 64).

  20. Insulin-like growth factor 1

    Insulin-like growth factor 1 (IGF-1) will be measured in plasma as on of the markers of environmental enteric dysfunction.

    Measured: Screening, Visits 2 (day 1) and 9 (day 64).

  21. Dietary intake

    Dietary intake will be captured using a quantified food frequency questionnaire.

    Measured: Screening, Visit 8 (day 29) and 15 (day 92).

  22. Method comparison in the measurement of RBP4 (µmol/L)

    Two methods will be compared in the measurement of RBP4 (µmol/L).

    Measured: Screening

  23. Method comparison in the measurement of Ferritin (µg/L)

    Two methods will be compared in the measurement of Ferritin (µg/L).

    Measured: Screening

  24. Method comparison in the measurement of sTfR (mg/L)

    Two methods will be compared in the measurement of sTfR (mg/L).

    Measured: Screening

  25. Method comparison in the measurement of CRP (mg/L)

    Two methods will be compared in the measurement of CRP (mg/L).

    Measured: Screening

  26. Method comparison in the measurement of AGP (g/L)

    Two methods will be compared in the measurement of AGP (g/L).

    Measured: Screening

  27. Method comparison in the measurement of I-FABP (pg/mL)

    Two methods will be compared in the measurement of I-FABP (pg/mL).

    Measured: Screening

  28. Method comparison in the measurement of Thyroglobulin (µg/L)

    Two methods will be compared in the measurement of Thyroglobulin (µg/L).

    Measured: Screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start1 Mar 2024
  3. Primary completion19 Nov 2024
  4. Study completion25 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06038656
Sponsor's protocol ID
F_ExerGOS
Acronym
FexerGOS
Status last verified
Mar 2025
First submitted
31 Aug 2023
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Galactooligosaccharides (GOS) in people with Resistance Exercise, run by North-West University, South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a. Fractional iron absorption (%) (time frame: Visit 8 (day 29) and 15 (day 92).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in