NCT05259969

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

January 17, 2022

Last Update Submit

April 8, 2022

Conditions

Keywords

athleteenergy availabilitynutritioneating disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Change in resting metabolic rate among different periods of a season

    Through study completion, an average of 1 year.

  • Change in body mass among different periods of a season

    Through study completion, an average of 1 year.

  • Change in fat free body mass among different periods of a season

    Through study completion, an average of 1 year.

  • Change in percentage of body fat among different periods of a season

    Through study completion, an average of 1 year.

  • Change in iron status markers among different periods of a season

    Through study completion, an average of 1 year.

  • +12 more secondary outcomes

Other Outcomes (3)

  • Change in lipid profile among different periods of a season

    Through study completion, an average of 1 year.

  • Change in leptin concentration among different periods of a season

    Through study completion, an average of 1 year.

  • Change in insulin-like growth factor 1 concentration among different periods of a season

    Through study completion, an average of 1 year.

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Under 15 years old, older than 40 years
  • Female
  • Para-athlete
  • Non active due to illness or injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 33095376BACKGROUND
  • Burke 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.

    PMID: 30029584BACKGROUND
  • Mountjoy 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.

    PMID: 29773536BACKGROUND
  • Sim 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.

    PMID: 33789771BACKGROUND
  • Reed 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.

    PMID: 23075047BACKGROUND
  • Staal 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.

    PMID: 29405782BACKGROUND
  • Zabriskie 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.

    PMID: 30813399BACKGROUND
  • Melin 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.

    PMID: 30632422BACKGROUND
  • Logue 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.

    PMID: 32245088BACKGROUND
  • Loucks 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.

    PMID: 21793767BACKGROUND
  • Mountjoy 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.

    PMID: 26764434BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Serum, Plasma, Stool samples

MeSH Terms

Conditions

Relative Energy Deficiency in SportFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nina Mohorko, PhD

    University of Primorska, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vesna Simič, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2022

First Posted

March 2, 2022

Study Start

May 1, 2022

Primary Completion

September 30, 2023

Study Completion

April 30, 2024

Last Updated

April 11, 2022

Record last verified: 2022-04