Relative Energy Deficiency in SportEAMASNCT05259969
Energy Availability in Male Athletes Across the Season
An observational study of Relative Energy Deficiency in Sport, run by University of Primorska.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Relative Energy Deficiency in Sport
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Adult
Study population: Olympic Committee of Slovenia recognized (categorized) competitive adult male athletes
Who may be able to join
- 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
Who cannot join
- Under 15 years old, older than 40 years
- Female
- Para-athlete
- Non active due to illness or injury
Trial locations and contacts
No sites are listed yet.
Vesna Simič, MSc contact
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Relative Energy Deficiency in Sport
- Keywords
- athlete, energy availability, nutrition, eating disorder
- Medical subject headings
- Relative Energy Deficiency in Sport, Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 1 year.
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
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.
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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
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.
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.
Measured: 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.
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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Relative Energy Deficiency in SportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Mohorko, University of Primorska
- Investigators
- Nina Mohorko, PhD, Principal investigator, University of Primorska, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259969
- Sponsor's protocol ID
- EAMAS
- Acronym
- EAMAS
- Status last verified
- Apr 2022
- First submitted
- 17 Jan 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Areta JL, Taylor HL, Koehler K. Low energy availability: history, definition and evidence of its endocrine, metabolic and physiological effects in prospective studies in females and males. Eur J Appl Physiol. 2021 Jan;121(1):1-21. doi: 10.1007/s00421-020-04516-0. Epub 2020 Oct 23.
PubMed 33095376Burke LM, Lundy B, Fahrenholtz IL, Melin AK. Pitfalls of Conducting and Interpreting Estimates of Energy Availability in Free-Living Athletes. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):350-363. doi: 10.1123/ijsnem.2018-0142. Epub 2018 Jul 20.
PubMed 30029584Mountjoy M, Sundgot-Borgen JK, Burke LM, Ackerman KE, Blauwet C, Constantini N, Lebrun C, Lundy B, Melin AK, Meyer NL, Sherman RT, Tenforde AS, Klungland Torstveit M, Budgett R. IOC consensus statement on relative energy deficiency in sport (RED-S): 2018 update. Br J Sports Med. 2018 Jun;52(11):687-697. doi: 10.1136/bjsports-2018-099193. No abstract available.
PubMed 29773536Sim A, Burns SF. Review: questionnaires as measures for low energy availability (LEA) and relative energy deficiency in sport (RED-S) in athletes. J Eat Disord. 2021 Mar 31;9(1):41. doi: 10.1186/s40337-021-00396-7.
PubMed 33789771Reed JL, De Souza MJ, Williams NI. Changes in energy availability across the season in Division I female soccer players. J Sports Sci. 2013;31(3):314-24. doi: 10.1080/02640414.2012.733019. Epub 2012 Oct 18.
PubMed 23075047Staal S, Sjodin A, Fahrenholtz I, Bonnesen K, Melin AK. Low RMRratio as a Surrogate Marker for Energy Deficiency, the Choice of Predictive Equation Vital for Correctly Identifying Male and Female Ballet Dancers at Risk. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):412-418. doi: 10.1123/ijsnem.2017-0327. Epub 2018 Jun 22.
PubMed 29405782Zabriskie HA, Currier BS, Harty PS, Stecker RA, Jagim AR, Kerksick CM. Energy Status and Body Composition Across a Collegiate Women's Lacrosse Season. Nutrients. 2019 Feb 23;11(2):470. doi: 10.3390/nu11020470.
PubMed 30813399Melin AK, Heikura IA, Tenforde A, Mountjoy M. Energy Availability in Athletics: Health, Performance, and Physique. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):152-164. doi: 10.1123/ijsnem.2018-0201. Epub 2019 Feb 26.
PubMed 30632422Logue DM, Madigan SM, Melin A, Delahunt E, Heinen M, Donnell SM, Corish CA. Low Energy Availability in Athletes 2020: An Updated Narrative Review of Prevalence, Risk, Within-Day Energy Balance, Knowledge, and Impact on Sports Performance. Nutrients. 2020 Mar 20;12(3):835. doi: 10.3390/nu12030835.
PubMed 32245088Loucks AB, Kiens B, Wright HH. Energy availability in athletes. J Sports Sci. 2011;29 Suppl 1:S7-15. doi: 10.1080/02640414.2011.588958. Epub 2011 Jul 28.
PubMed 21793767Mountjoy M, Sundgot-Borgen J, Burke L, Carter S, Constantini N, Lebrun C, Meyer N, Sherman R, Steffen K, Budgett R, Ljungqvist A, Ackerman K. The IOC relative energy deficiency in sport clinical assessment tool (RED-S CAT). Br J Sports Med. 2015 Nov;49(21):1354. No abstract available.
PubMed 26764434
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Availability, Eating Disorder and RED-S Risk, Health Biomarkers, Gut Microbiota Composition and Performance in Competitive Male Athletes Across the Season
- ClinicalTrials.gov ID
- NCT05259969
- Acronym / sponsor ID
- EAMAS / EAMAS
- Conditions
- Relative Energy Deficiency in Sport
- Keywords
- athlete, energy availability, nutrition, eating disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Olympic Committee of Slovenia recognized (categorized) competitive adult male athletes
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Under 15 years old, older than 40 years
- Female
- Para-athlete
- Non active due to illness or injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
17 secondary outcomes
Change in resting metabolic rate among different periods of a season
Time frame: 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.
Change in fat free body mass among different periods of a season
Time frame: 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.
Change in iron status markers among different periods of a season
Time frame: 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.
Change in testosteron concentration among different periods of a season
Time frame: 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.
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.
Change in Eating Attitude Test-26 score among different periods of a season
Time frame: 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.
Change in inflammation markers among different periods of a season
Time frame: 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.
Change in growth hormone concentration among different periods of a season
Time frame: 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.
Change in metabolite concentration among different periods of a season
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Background: PubMed 33095376Areta JL, Taylor HL, Koehler K. Low energy availability: history, definition and evidence of its endocrine, metabolic and physiological effects in prospective studies in females and males. Eur J Appl Physiol. 2021 Jan;121(1):1-21. doi: 10.1007/s00421-020-04516-0. Epub 2020 Oct 23.
- Background: PubMed 30029584Burke LM, Lundy B, Fahrenholtz IL, Melin AK. Pitfalls of Conducting and Interpreting Estimates of Energy Availability in Free-Living Athletes. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):350-363. doi: 10.1123/ijsnem.2018-0142. Epub 2018 Jul 20.
- Background: PubMed 29773536Mountjoy M, Sundgot-Borgen JK, Burke LM, Ackerman KE, Blauwet C, Constantini N, Lebrun C, Lundy B, Melin AK, Meyer NL, Sherman RT, Tenforde AS, Klungland Torstveit M, Budgett R. IOC consensus statement on relative energy deficiency in sport (RED-S): 2018 update. Br J Sports Med. 2018 Jun;52(11):687-697. doi: 10.1136/bjsports-2018-099193. No abstract available.
- Background: PubMed 33789771Sim A, Burns SF. Review: questionnaires as measures for low energy availability (LEA) and relative energy deficiency in sport (RED-S) in athletes. J Eat Disord. 2021 Mar 31;9(1):41. doi: 10.1186/s40337-021-00396-7.
- Background: PubMed 23075047Reed JL, De Souza MJ, Williams NI. Changes in energy availability across the season in Division I female soccer players. J Sports Sci. 2013;31(3):314-24. doi: 10.1080/02640414.2012.733019. Epub 2012 Oct 18.
- Background: PubMed 29405782Staal S, Sjodin A, Fahrenholtz I, Bonnesen K, Melin AK. Low RMRratio as a Surrogate Marker for Energy Deficiency, the Choice of Predictive Equation Vital for Correctly Identifying Male and Female Ballet Dancers at Risk. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):412-418. doi: 10.1123/ijsnem.2017-0327. Epub 2018 Jun 22.
- Background: PubMed 30813399Zabriskie HA, Currier BS, Harty PS, Stecker RA, Jagim AR, Kerksick CM. Energy Status and Body Composition Across a Collegiate Women's Lacrosse Season. Nutrients. 2019 Feb 23;11(2):470. doi: 10.3390/nu11020470.
- Background: PubMed 30632422Melin AK, Heikura IA, Tenforde A, Mountjoy M. Energy Availability in Athletics: Health, Performance, and Physique. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):152-164. doi: 10.1123/ijsnem.2018-0201. Epub 2019 Feb 26.
- Background: PubMed 32245088Logue DM, Madigan SM, Melin A, Delahunt E, Heinen M, Donnell SM, Corish CA. Low Energy Availability in Athletes 2020: An Updated Narrative Review of Prevalence, Risk, Within-Day Energy Balance, Knowledge, and Impact on Sports Performance. Nutrients. 2020 Mar 20;12(3):835. doi: 10.3390/nu12030835.
- Background: PubMed 21793767Loucks AB, Kiens B, Wright HH. Energy availability in athletes. J Sports Sci. 2011;29 Suppl 1:S7-15. doi: 10.1080/02640414.2011.588958. Epub 2011 Jul 28.
- Background: PubMed 26764434Mountjoy M, Sundgot-Borgen J, Burke L, Carter S, Constantini N, Lebrun C, Meyer N, Sherman R, Steffen K, Budgett R, Ljungqvist A, Ackerman K. The IOC relative energy deficiency in sport clinical assessment tool (RED-S CAT). Br J Sports Med. 2015 Nov;49(21):1354. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vesna Simič, MSc contact
Nina Mohorko, PhD principal investigator
University of Primorska, Faculty of Health Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Relative Energy Deficiency in Sport, run by University of Primorska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina Mohorko, PhD (+386 5 66 35 801, nina.mohorko@fvz.upr.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in energy availability among different periods of a season (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259969, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.