Energy Availability in Male Athletes Across the Season (EAMAS)

April 8, 2022 updated by: Nina Mohorko, University of Primorska

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Olympic Committee of Slovenia recognized (categorized) competitive adult male athletes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in energy availability among different periods of a season
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
Serum testosterone concentration will be measured.
Through study completion, an average of 1 year.
Change in cortisol concentration among different periods of a season
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
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
Time Frame: Through study completion, an average of 1 year.
Sports specific performance test will be performed.
Through study completion, an average of 1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lipid profile among different periods of a season
Time Frame: Through study completion, an average of 1 year.
Serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides concentrations will be measured.
Through study completion, an average of 1 year.
Change in leptin concentration among different periods of a season
Time Frame: Through study completion, an average of 1 year.
Serum leptin concentration will be measured.
Through study completion, an average of 1 year.
Change in insulin-like growth factor 1 concentration among different periods of a season
Time Frame: Through study completion, an average of 1 year.
Serum Insulin-like growth factor 1 concentration will be measured.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Primorska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

September 30, 2023

Study Completion (ANTICIPATED)

April 30, 2024

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (ACTUAL)

March 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAMAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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