Oslo Footballplayers Iron Supplementation and Training (FIT) Study

Microbiota Clinical Trial

— Oslo-FIT  

Official title:

Iron Intake, Iron Status, Intestinal Health and Endurance Performance - Effects of Iron Supplementation in Young Female Football Players - a Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04526678
• Other study ID #: 969159570_KBM_SKB2020
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 11, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: August 2020
• Source: Norwegian University of Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to characterize the diet and iron status of young female elite football players and examine the relationship between iron intake, iron status, hemoglobin levels, intestinal health and sports performance. In addition, the effects of low-dose iron supplements on iron stores will be investigated and whether such supplementation affects intestinal health, microbiota composition and biomarkers for oxidative stress.

Description:

Iron deficiency can lead to fatigue and anemia. Because iron is necessary for the formation of new blood cells (hematopoiesis), it is an extensive practice internationally among athletes to take iron supplements in the belief that this will improve endurance performance and oxygen transport capacity by increasing red blood cell production. Although iron intake in menstruating women has shown to reduce the prevalence of anemia and iron deficiency as well as increasing hemoglobin values and iron stores. However iron supplementation increases the risk of iron excess and can result in undesirable effects such as constipation and abdominal pain as well as negative impact on intestinal epithelial permeability and increase in oxidative stress. Because iron is important for the replication and survival of almost all bacteria, with few exceptions, the intake of iron also affect the composition of the intestinal bacteria. Not surprisingly, both high and low iron levels affect the composition of the microbiota in the gut.

It is not known if young menstruating Norwegian female athletes cover their need for iron via the diet or whether extra intake in the form of a low-dose supplement could be beneficial in terms of hemoglobin levels and sports performance. Because iron preparations are not prescription and are sold in pharmacies, health food stores and larger grocery stores, this can lead to uncritical intake of iron. Since the use of iron preparations has been documented to be widespread in foreign sports environments, it is important to both characterize the iron status of Norwegian athletes and at the same time examine the beneficial value of iron supplements on sports performance as well as monitoring effects on microbiota composition and intestinal health.

The aim of the study is therefore to characterize the diet and iron status of young female elite football players and examine the relationship between iron intake, iron status, hemoglobin levels, intestinal health and sports performance. In addition, the effects of low-dose iron supplements will be investigated in relation to iron stores, hemoglobin levels and sports performance and whether such supplementation affects intestinal health, microbiota composition and biomarkers for oxidative stress.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 26
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Female elite football players from two selected football clubs

Exclusion Criteria:

• Pregnancy

• Medical conditions that are worsened by taking iron supplements

• Already taking iron supplements

Related Conditions & MeSH terms

• Athletes
• Endurance Performance
• Hemoglobin
• Intestinal Health
• Iron
• Microbiota

Intervention

Dietary Supplement:
• Iron supplement (27mg)
The participants will be randomized to an intervention group or a control group. The intervention group will ingest 27mg iron daily for three months.

Locations

Country	Name	City	State
Norway	Norwegian University of Life Sciences	Ås

Sponsors (4)

Lead Sponsor	Collaborator
Ågot Aakra	Norwegian Olympic Sports Centre, Norwegian School of Sport Sciences, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet composition	Diet composition will be assessed using digital 7 day dietary records.	3 months
Primary	Iron intake	Iron intake will be calculated based on average daily intake of iron according to the digital 7 day dietary recordings.	3 months
Primary	Serum Iron	Iron status will be assessed by analyzing serum iron (µmol/L)	3 months
Primary	Serum transferrin	Iron status will be assessed by analyzing serum transferrin (µmol/L)	3 months
Primary	Serum ferritin	Iron status will be assessed by analyzing serum ferritin (µg/L)	3 months
Primary	Hemoglobin levels	hemoglobin (Hb) (g/dl) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.	3 months
Primary	LPS binding protein	-Intestinal health will be measured using biomarkers of intestinal leakage in serum and feces such as sLPS binding protein (LBP) (ug/ml)	3 months
Primary	Neutrophil gelatinase-associated lipocalin	-Intestinal health will be measured using biomarkers of intestinal leakage in serum and feces such as fecal neutrophil gelatinase-associated lipocalin (NGAL) (ng/g feces)	3 months
Primary	Serum cytokines	-Intestinal health will be measured using serum biomarkers of systemic inflammation (e.g. serum cytokines such as IL-1, IL-6, and TNF-a pg/ml).	3 months
Primary	Sports performance	Sports performance specific for football will be be measured using the Yo-Yo Intermittent Recovery Test (YYIR1).	3 months
Primary	Differential counts	Differential counts (% of WBC) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.	3 months
Primary	Ferric reducing ability of plasma	-Oxidative stress will be assessed measuring the ferric reducing ability of plasma (FRAP)	3 months
Primary	Diacron reactive oxygen metabolites	-Oxidative stress will be assessed measuring biomarkers of total oksidativ stress e.g. diacron reactive oxygen metabolites (dROM).	3 months
Primary	Microbiota composition	-Microbiota composition will be analyzed mainly using 16S rRNA gene sequencing. The main effect of the intervention on the microbiota will be tested based on crude alpha and beta diversity indices but we will also apply advanced multivariate methods.	3 months