Este Vorster Research Facility
Potchefstroom, North West, 2531, South Africa
NCT Number: NCT06038656
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.
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Notify Me18 year–35 year
Female
Interventional
Not applicable
Potchefstroom, North West, 2531, South Africa
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Visit 8 (day 29) and 15 (day 92).
Fractional iron absorption will be measured at rest and after an exercise bout.
Time frame: Visit 8 (day 29) and 15 (day 92).
Fractional iron absorption will be measured after an exercise bout with and without co-administration of GOS.
Time frame: Visit 8 (day 29) and 15 (day 92).
Fractional iron absorption will be measured at rest and after an exercise bout before and after a 6-week intervention with GOS.
Time frame: 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)
Interleukin 6 (IL-6) will be measured over 24 hours after rest and after exercise as a marker of exercise-induced inflammation.
Time frame: Visits 2 (day 1), 4 (day 8), 6 (day 15), 9 (day 64), 11 (day 71) and 13 (day 78).
C-reactive protein (CRP) will be measured in plasma to detect the presence of acute inflammation.
Time frame: Visits 2 (day 1), 4 (day 8), 6 (day 15), 9 (day 64), 11 (day 71) and 13 (day 78).
Alpha-1-acid glycoprotein (AGP) will be measured in plasma to determine the presence of chronic inflammation.
Time frame: 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)
Hepcidin, a major regulator of iron absorption and influenced by exercise-induced inflammation, will be measured in plasma over 24 hours.
Time frame: 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)
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).
Time frame: Visits 2 (day 1), 4 (day 8), 6 (day 15), 9 (day 64), 11 (day 71) and 13 (day 78).
Plasma erythropoietin, a marker of erythropoiesis, will be measured before and after period of rest and exercise.
Time frame: 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).
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.
Time frame: Visit 8 (day 29) and 15 (day 92).
Gut microbiota profile will be assessed at baseline and endpoint.
Time frame: Visit 8 (day 29) and 15 (day 92).
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.
Time frame: Visit 8 (day 29) and 15 (day 92).
Faecal pH will be measured at baseline and endpoint to determine a response to the GOS intervention.
Time frame: Visit 8 (day 29) and 15 (day 92).
Faecal calprotectin will be measured at baseline and endpoint as a marker of gut inflammation.
Time frame: Visit 8 (day 29) and 15 (day 92).
Faecal zonulin will be measured at baseline and endpoint as a marker of the integrity of the intestinal mucosal barrier.
Time frame: Screening, Visits 4 (day 8), 8 (day 29), 9 (day 64), 11 (day 71) and 15 (day 92).
Intestinal fatty acid-binding protein (I-FABP), a marker of intestinal damage, will be measured in plasma at baseline and endpoint.
Time frame: Screening,Visit 8 (day 29), 9 (day 64) and 15 (day 92).
Haemoglobin will be measured in whole blood to determine presence of anaemia and for calculation of fractional iron absorption.
Time frame: Screening, Visits 2 (day 1) and 9 (day 64).
Ferritin will be measured in plasma to determine the presence of iron deficiency.
Time frame: Screening, Visits 2 (day 1) and 9 (day 64).
Soluble transferrin receptor (sTfR) will be measured in plasma to determine the presence of iron deficiency.
Time frame: Screening, Visits 2 (day 1) and 9 (day 64).
Retinol-binding protein 4 (RBP4) will be measured in plasma as a marker of vitamin A status.
Time frame: Screening, Visits 2 (day 1) and 9 (day 64).
Thyroglobulin will be measured in plasma as a marker of iodine status.
Time frame: Screening,Visits 2 (day 1) and 9 (day 64).
Fibroblast growth factor 21 (FGF-21) will be measured in plasma as a marker of environmental enteric dysfunction (EED).
Time frame: Screening, Visits 2 (day 1) and 9 (day 64).
Insulin-like growth factor 1 (IGF-1) will be measured in plasma as on of the markers of environmental enteric dysfunction.
Time frame: Screening, Visit 8 (day 29) and 15 (day 92).
Dietary intake will be captured using a quantified food frequency questionnaire.
Time frame: Screening
Two methods will be compared in the measurement of RBP4 (µmol/L).
Time frame: Screening
Two methods will be compared in the measurement of Ferritin (µg/L).
Time frame: Screening
Two methods will be compared in the measurement of sTfR (mg/L).
Time frame: Screening
Two methods will be compared in the measurement of CRP (mg/L).
Time frame: Screening
Two methods will be compared in the measurement of AGP (g/L).
Time frame: Screening
Two methods will be compared in the measurement of I-FABP (pg/mL).
Time frame: Screening
Two methods will be compared in the measurement of Thyroglobulin (µg/L).
North-West University, South Africa
Other
Effects of Exercise and Acute and Chronic Galactooligosaccharide Supplementation on Inflammation and Iron Absorption in Female Athletes
Acronym: FexerGOS
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