Energy Availability in Male Athletes Across the Season

Study Overview
=================
Brief Summary
-----------------
The aim of proposed cohort observational study is assessing the risk of low energy availability and relative energy deficiency in sport in competitive adult male athletes. The changes in athlete's energy availability, health biomarkers in blood, gut microbiota composition and performance will be determined in 3 key stages across the season: during preparation, competition and transition period in a subset of athletes. The study is investigating following specific aims in the cohort of male competitive athletes: Correlation between energy availability and resting metabolic rate and metabolic functions across the season. Correlation between energy availability and reproductive functions across the season. Correlation between energy availability and hematological biomarkers across the season. Correlation between energy availability and gut microbiota composition across the season. Correlation between energy availability and performance across the season.

Detailed Description
-----------------
As the initial part of the research the screening for low energy availability, RED-S and eating disorder risk in a larger group of competitive athletes recognized by Olympic Committee of Slovenia will be performed via combination of validated and semi-validated questionnaires: Low Energy Availability in Males Questionnaire, RED-S specific screening tool, Eating Attitude Test (EAT-26) and Eating disorder Inventory - Drive for thinness score. 25 competitive male athletes will be invited for participation in the continuation phase of the research. Depending on the type of sports, we will define appropriate time intervals for 3 planned laboratory visits. The first visit is planned in the preparation phase, when the workload, given the periodization of the training, is at its peak. The second visit is planned in the competition phase (presumably 6 moths after the 1st visit) and the third one in the transition phase, when the exercise load is the lowest. The subjects will be informed about the procedure and the aim of the testing prior to its initiation at the introduction meeting. They will be notified about the right to terminate their participation at any moment. Prior to the initiation of the research they will be asked to sign the informed consent form. By doing that they will be informed about the exact procedure regarding how they will be required to keep a 4 day nutrition records with weighted quantities of food and how to keep the log regarding their physical activity. All subjects will be equipped with the acceleration meter. In the framework of each laboratory visit, the subjects will come fasted, provide a stool sample and fill in the questionnaires, while we will perform anthropometric measurements, resting metabolic rate measurement by using the indirect calorimetry method in draw a venous blood sample. At the end of the visit, participants will undergo a performance test.

Official Title
-----------------
Energy Availability, Eating Disorder and RED-S Risk, Health Biomarkers, Gut Microbiota Composition and Performance in Competitive Male Athletes Across the Season

Conditions
-----------------
Relative Energy Deficiency in Sport

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: National Sport Organization identified competitive female or male athlete Male athlete actively training for and racing in an Olympic sports event Age 18-40 years Exclusion Criteria: Under 15 years old, older than 40 years Female Para-athlete Non active due to illness or injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in energy availability among different periods of a season | Energy intake (kcal/day), energy expenditure (kcal/day) and fat free mass (FFM; kg) will be combined to report energy availability (kcal/kg FFM/day). | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in resting metabolic rate among different periods of a season | Resting metabolic rate will be determined with indirect calorimeter and predicted with validated equations and expressed in kJ/day. | Through study completion, an average of 1 year. | 
| Change in body mass among different periods of a season | Body mass will be measured to the nearest 0.01 kg. | Through study completion, an average of 1 year. | 
| Change in fat free body mass among different periods of a season | Fat free body mass (FFM [kg]) will be measured with bioelectrical impedance. | Through study completion, an average of 1 year. | 
| Change in percentage of body fat among different periods of a season | Percentage body fat [%] will be measured with bioelectrical impedance. | Through study completion, an average of 1 year. | 
| Change in iron status markers among different periods of a season | Serum iron, haemoglobin, ferritin, transferrin and hepcidin concentrations will be measured. | Through study completion, an average of 1 year. | 
| Change in thyroid markers among different periods of a season | Serum thyroid-stimulating hormone, triiodothyronine and thyroxine concentrations will be measured. | Through study completion, an average of 1 year. | 
| Change in testosteron concentration among different periods of a season | Serum testosterone concentration will be measured. | Through study completion, an average of 1 year. | 
| Change in cortisol concentration among different periods of a season | Serum cortisol concentration will be measured. | Through study completion, an average of 1 year. | 
| Change in Low Energy Availability in Males Questionnaire score among different periods of a season | Low Energy Availability in Males Questionnaire (LEAM-Q) is male-adapted Low Energy Availability in Females Questionnaire by omitting female-speciffic questions. Score range 0-19, higher scores point to higher risk for relative energy deficiency in sport. | Through study completion, an average of 1 year. | 
| Change in Eating Attitude Test-26 score among different periods of a season | Eating disorder risk will be assessed with Eating Attitude Test (EAT-26). Score range 0-78, higher scores point to higher risk for eating disorder. | Through study completion, an average of 1 year. | 
| Change in Eating disorder Inventory - Drive for thinness score among different periods of a season | Drive for thinness will be assessed with Eating disorder Inventory- Drive for thinness questionnaire (EDI-DT). Score range 0-21, higher scores point to higher fat phobia. | Through study completion, an average of 1 year. | 
| Change in inflammation markers among different periods of a season | Serum C-reactive protein and interleukine-6 concentration will be measured. | Through study completion, an average of 1 year. | 
| Change in ghrelin concentration among different periods of a season | Serum ghrelin concentration will be measured. | Through study completion, an average of 1 year. | 
| Change in growth hormone concentration among different periods of a season | Serum growth hormone concentration will be measured. | Through study completion, an average of 1 year. | 
| Change in gut microbiota composition among different periods of a season | Gut microbiota will be analysed from stool samples. | Through study completion, an average of 1 year. | 
| Change in metabolite concentration among different periods of a season | Serum glucose, lactate and beta-hydroxybutyrate concentrations will be measured. | Through study completion, an average of 1 year. | 
| Change in sport performance among different periods of a season | Sports specific performance test will be performed. | Through study completion, an average of 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
athlete, energy availability, nutrition, eating disorder