NCT06371963

Brief Summary

Background: Relative Energy Deficiency in Sport (REDs) describes impairment of health and performance due to problematic (long-term/severe) low energy availability (LEA), with or without eating disorders. LEA is frequently reported in sports with high training volumes, especially in leanness demanding sports, and 20% of female and 9% of male Norwegian national team athletes have been reported to have eating disorders. Potential trigger factors are e.g., dieting, injuries, coaching behavior, and subculture aspects e.g., focus on low body weight. The main questions that will be addressed are: 1. What is the prevalence of eating disorders and REDs among Swedish elite athletes and controls? 2. What is the impact of problematic LEA on health and performance aspects in both male and female athletes? Methods: National team athletes and gender and matched controls will be invited to an anonymous on-line survey. Elite athletes who agree to participate, will be invited to assessment of eating disorders, nutritional and physiological status (e.g., metabolic and endocrine markers, bone health, microbiota, dietary intake, energy availability, and performance).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 10, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

March 10, 2025

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

February 26, 2024

Last Update Submit

March 6, 2025

Conditions

Keywords

Observational studyREDsEating disordersCross-sectional studyElite athletesSwedenPhysiological assessmentsPerformanceMicrobiotaImmune functionResting metabolic rateEnergy availabilityBiomarkersReproductive dysfunctionThe biological passportExercise addictionGastrointestinal function

Outcome Measures

Primary Outcomes (1)

  • Self-reported eating disorders

    Participants: Female and male elite athletes and age and gender matched controls. An on-line version of the Eating Disorder Examination Questionnaire (EDE-Q) will be used comprising of 28 items, 4 sub-scales (restrained eating, eating-, body-, and weight concerns), and a global score. An EDE-Q global score ≥ 2.3 for females and ≥1.7 for males indicate risk of eating disorder.

    Day one

Secondary Outcomes (23)

  • Eating disorders

    Through study completion, an average of 1 year

  • Self-reported reproductive function in females not using hormonal contraceptives

    Day one

  • Reproductive function in females not using hormonal contraceptives

    Through study completion, an average of 1 year

  • Self-reported reproductive function in males

    Day one

  • Reproductive function in males

    Through study completion, an average of 1 year

  • +18 more secondary outcomes

Study Arms (2)

Elite Athletes

Senior Swedish male and female national team and recruiting squad athletes.

Gender and age matched controls

Healthy male and female non-elite athletic controls.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Swedish male and female national team athletes and gender- and age matched controls.

You may qualify if:

  • National-team level athletes
  • Non-elite athletic controls
  • chronic illness (e.g., diabetes, hypothyroidism)
  • injury
  • smoking
  • pregnancy
  • hormonal contraceptive use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linnaeus University

Kalmar, Småland, Sweden

Location

Related Publications (19)

  • Mountjoy M, Ackerman KE, Bailey DM, Burke LM, Constantini N, Hackney AC, Heikura IA, Melin A, Pensgaard AM, Stellingwerff T, Sundgot-Borgen JK, Torstveit MK, Jacobsen AU, Verhagen E, Budgett R, Engebretsen L, Erdener U. 2023 International Olympic Committee's (IOC) consensus statement on Relative Energy Deficiency in Sport (REDs). Br J Sports Med. 2023 Sep;57(17):1073-1097. doi: 10.1136/bjsports-2023-106994.

    PMID: 37752011BACKGROUND
  • Melin A, Tornberg AB, Skouby S, Moller SS, Sundgot-Borgen J, Faber J, Sidelmann JJ, Aziz M, Sjodin A. Energy availability and the female athlete triad in elite endurance athletes. Scand J Med Sci Sports. 2015 Oct;25(5):610-22. doi: 10.1111/sms.12261. Epub 2014 May 30.

    PMID: 24888644BACKGROUND
  • 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
  • Heikura IA, Uusitalo ALT, Stellingwerff T, Bergland D, Mero AA, Burke LM. Low Energy Availability Is Difficult to Assess but Outcomes Have Large Impact on Bone Injury Rates in Elite Distance Athletes. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):403-411. doi: 10.1123/ijsnem.2017-0313. Epub 2018 Jun 12.

    PMID: 29252050BACKGROUND
  • Lundy SD, Sangwan N, Parekh NV, Selvam MKP, Gupta S, McCaffrey P, Bessoff K, Vala A, Agarwal A, Sabanegh ES, Vij SC, Eng C. Functional and Taxonomic Dysbiosis of the Gut, Urine, and Semen Microbiomes in Male Infertility. Eur Urol. 2021 Jun;79(6):826-836. doi: 10.1016/j.eururo.2021.01.014. Epub 2021 Feb 8.

    PMID: 33573862BACKGROUND
  • Hackney AC, Lane AR, Register-Mihalik J, O'leary CB. Endurance Exercise Training and Male Sexual Libido. Med Sci Sports Exerc. 2017 Jul;49(7):1383-1388. doi: 10.1249/MSS.0000000000001235.

    PMID: 28195945BACKGROUND
  • 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
  • Konda R, Orikasa S. [Studies on reflux nephropathy, I. Evaluation of renal function by urinary excretion of beta 2-microglobulin]. Nihon Hinyokika Gakkai Zasshi. 1984 Feb;75(2):245-54. No abstract available. Japanese.

    PMID: 6379250BACKGROUND
  • Rankin A, O'Donovan C, Madigan SM, O'Sullivan O, Cotter PD. 'Microbes in sport' -The potential role of the gut microbiota in athlete health and performance. Br J Sports Med. 2017 May;51(9):698-699. doi: 10.1136/bjsports-2016-097227. Epub 2017 Jan 25. No abstract available.

    PMID: 28432108BACKGROUND
  • Tornberg AB, Melin A, Koivula FM, Johansson A, Skouby S, Faber J, Sjodin A. Reduced Neuromuscular Performance in Amenorrheic Elite Endurance Athletes. Med Sci Sports Exerc. 2017 Dec;49(12):2478-2485. doi: 10.1249/MSS.0000000000001383.

    PMID: 28723842BACKGROUND
  • Griffiths MD, Szabo A, Terry A. The exercise addiction inventory: a quick and easy screening tool for health practitioners. Br J Sports Med. 2005 Jun;39(6):e30. doi: 10.1136/bjsm.2004.017020.

    PMID: 15911594BACKGROUND
  • Melin A, Tornberg AB, Skouby S, Faber J, Ritz C, Sjodin A, Sundgot-Borgen J. The LEAF questionnaire: a screening tool for the identification of female athletes at risk for the female athlete triad. Br J Sports Med. 2014 Apr;48(7):540-5. doi: 10.1136/bjsports-2013-093240. Epub 2014 Feb 21.

    PMID: 24563388BACKGROUND
  • Peman J, Peset V, Salavert M, Carreras C, Esteban G. [Microcytic anemia and coproparasitologic findings in a 3-year-old boy]. Enferm Infecc Microbiol Clin. 1997 Feb;15(2):111-2. No abstract available. Spanish.

    PMID: 9101736BACKGROUND
  • Bech P, Timmerby N, Martiny K, Lunde M, Soendergaard S. Psychometric evaluation of the Major Depression Inventory (MDI) as depression severity scale using the LEAD (Longitudinal Expert Assessment of All Data) as index of validity. BMC Psychiatry. 2015 Aug 5;15:190. doi: 10.1186/s12888-015-0529-3.

    PMID: 26242577BACKGROUND
  • Lundgren T, Parling T. Swedish Acceptance and Action Questionnaire (SAAQ): a psychometric evaluation. Cogn Behav Ther. 2017 Jun;46(4):315-326. doi: 10.1080/16506073.2016.1250228. Epub 2016 Dec 9.

    PMID: 27931161BACKGROUND
  • Gard G, Rivano M, Grahn B. Development and reliability of the Motivation for Change Questionnaire. Disabil Rehabil. 2005 Sep 2;27(17):967-76. doi: 10.1080/09638280500052682.

    PMID: 16096250BACKGROUND
  • Vanheest JL, Rodgers CD, Mahoney CE, De Souza MJ. Ovarian suppression impairs sport performance in junior elite female swimmers. Med Sci Sports Exerc. 2014 Jan;46(1):156-66. doi: 10.1249/MSS.0b013e3182a32b72.

    PMID: 23846160BACKGROUND
  • Woods AL, Rice AJ, Garvican-Lewis LA, Wallett AM, Lundy B, Rogers MA, Welvaert M, Halson S, McKune A, Thompson KG. The effects of intensified training on resting metabolic rate (RMR), body composition and performance in trained cyclists. PLoS One. 2018 Feb 14;13(2):e0191644. doi: 10.1371/journal.pone.0191644. eCollection 2018.

    PMID: 29444097BACKGROUND
  • Loucks AB, Thuma JR. Luteinizing hormone pulsatility is disrupted at a threshold of energy availability in regularly menstruating women. J Clin Endocrinol Metab. 2003 Jan;88(1):297-311. doi: 10.1210/jc.2002-020369.

    PMID: 12519869BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Gut microbiota composition bacterial DNA from fecal samples,whole blood, serum (only eligible elite athletes participating in physiological testing, anticipated n=44).

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

  • Anna Melin, PhD

    Linnaeus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 26, 2024

First Posted

April 17, 2024

Study Start

May 10, 2022

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

March 10, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations