Oslo Footballplayers Iron Supplementation and Training (FIT) Study (Oslo-FIT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Athletes; Endurance Performance; Microbiota; Iron; Hemoglobin; Intestinal Health
• Intervention / Treatment: Dietary supplement: Iron supplement (27mg)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Ås, Norway, 1433
    • Norwegian University of Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Iron supplements; The intervention group will ingest 27 mg iron supplement per day for three months while the control group will not ingest iron supplements.	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.
NO_INTERVENTION: Control group; The control group will not ingest iron supplements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet composition	Diet composition will be assessed using digital 7 day dietary records.	3 months
Iron intake	Iron intake will be calculated based on average daily intake of iron according to the digital 7 day dietary recordings.	3 months
Serum Iron	Iron status will be assessed by analyzing serum iron (µmol/L)	3 months
Serum transferrin	Iron status will be assessed by analyzing serum transferrin (µmol/L)	3 months
Serum ferritin	Iron status will be assessed by analyzing serum ferritin (µg/L)	3 months
Hemoglobin levels	hemoglobin (Hb) (g/dl) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.	3 months
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
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
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-α pg/ml).	3 months
Sports performance	Sports performance specific for football will be be measured using the Yo-Yo Intermittent Recovery Test (YYIR1).	3 months
Differential counts	Differential counts (% of WBC) will be analyzed in whole blood (EDTA) using an automated hematology analyzer.	3 months
Ferric reducing ability of plasma	-Oxidative stress will be assessed measuring the ferric reducing ability of plasma (FRAP)	3 months
Diacron reactive oxygen metabolites	-Oxidative stress will be assessed measuring biomarkers of total oksidativ stress e.g. diacron reactive oxygen metabolites (dROM).	3 months
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

Collaborators and Investigators

• Sponsor: Ågot Aakra
• Collaborators: University of Oslo; Norwegian School of Sport Sciences; Norwegian Olympic Sports Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 11, 2020
• Primary Completion (ANTICIPATED): November 20, 2020
• Study Completion (ANTICIPATED): November 20, 2020

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (ACTUAL): August 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: oxidative stress; football
• Other Study ID Numbers: 969159570_KBM_SKB2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: An IPD sharing plan is not ready for the project

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No