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

NCT06038656 | Completed DMC

• 1 other identifier: F_ExerGOS
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resistance Exercise

Keywords

Galacto-oligosaccharides; female athletes; iron absorption; inflammation

Outcome Measures

Primary Outcomes (3)

• a. Fractional iron absorption (%)

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

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

• b. Fractional iron absorption (%)

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

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

• 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.

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

Secondary Outcomes (28)

• Interleukin 6 (pg/mL)

  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)

• C-reactive protein (mg/L)

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

• Alpha-1-acid glycoprotein (g/L)

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

• Hepcidin (ng/mL)

  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)

• Lipid mediators (pg/µL )

  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)

Study Arms (1)

Experimental

EXPERIMENTAL

Participants 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.

Dietary Supplement: Galactooligosaccharides (GOS)

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• North-West University, South Africa: lead
• Swiss Federal Institute of Technology: collaborator
• King's College London: collaborator

Study Sites (1)

Este Vorster Research Facility

Potchefstroom, North West, 2531, South Africa

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabelle Herter-Aeberli

  ETH Zurich

  PRINCIPAL INVESTIGATOR

• Jesslee du Plessis

  North-West University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 15, 2023
• Study Start: March 1, 2024
• Primary Completion: November 19, 2024
• Study Completion: November 25, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)