NCT06220240

Brief Summary

Energy availability (EA) refers to the balance between daily energy intake and exercise energy expenditure. Athletically inadequate EA is defined as low energy availability (LEA). Energy deficits occur throughout life, from young athletes with a relative lack of energy in sports or the female athlete triad to older adults struggling with weight loss. Acute and/or chronic LEA can cause negative athletic and health outcomes in athletes. It is known that LEA, as an energy saving mechanism, suppresses the reproductive system and causes disruption of the menstrual cycle, as well as causing many interrelated endocrine-related physiological consequences by changing other hormonal pathways. Menstrual dysfunction due to LEA causes various risks as it can disrupt the EC during training and competition. Therefore, low EA may contribute to poor sports performance due to detrimental endocrine effects. Various parameters such as body mass and nutritional intake affect the performance of athletes, and LEA is frequently reported among athletes with intense training programs. LEA combined with high training volumes; It can cause negative consequences such as impaired protein synthesis/degradation rate, impaired hormonal and training response, increased risk of fatigue, and these can lead to decreased performance. Resting metabolic rate, which indicates the energy expended for basic body functions, is considered a potential objective indicator of energy availability. Regulation of dietary energy intake in the management of LEA in athletes covers a wide area in the literature. However, LEA is caused not only by a deficiency in energy intake but also by an excess in energy expenditure. In the light of this information, the aim of the study is to examine the acute period effects of the training program in which exercise energy expenditure is reduced in terms of energy availability and athletic performance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

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 11, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 11, 2024

Last Update Submit

January 22, 2024

Conditions

Keywords

Energy DeficiencyEccentric ExerciseAthletic Performans

Outcome Measures

Primary Outcomes (5)

  • Energy Availability

    The underlying etiology of Relative Energy Deficiency in Sports is low energy availability, which occurs when dietary energy intake is inadequate for an athlete's physical activity level. "Energy availability = Energy Intake (kcal) - Exercise Energy Expenditure (kcal/fat - free mass \[fat free mass; kg\])"

    change from baseline pain at 2 weeks

  • Relative Energy Deficiency in Sports Clinical Assessment Tool (RED-S CAT)

    It is a clinical assessment tool used to evaluate athletes or active individuals with suspected low energy availability and serves as a guide for clinicians and coaches in return-to-play decisions.

    3 times for 2 weeks

  • Running Performance Analysis - Biomechanics

    Performance analysis will be performed on a 10-meter platform with DigitSole in order to evaluate the biomechanics.

    3 times for 2 weeks

  • Running Performance Analysis - Running Speed

    Performance analysis will be performed on a 10-meter platform with DigitSole in order to evaluate the running speed.

    3 times for 2 weeks

  • Running Performance Analysis - Economy of the Running

    Performance analysis will be performed on a 10-meter platform with DigitSole in order to evaluate the economy of the athlete's running activity.

    3 times for 2 weeks

Secondary Outcomes (6)

  • Gonadotropin-Releasing Hormone Levels

    3 times for 2 weeks

  • Adrenocorticotropic Hormone Levels

    3 times for 2 weeks

  • thyroid stimulating Hormone Levels

    3 times for 2 weeks

  • Luteinizing Hormone Levels

    3 times for 2 weeks

  • Follicle-stimulating Hormone Levels

    3 times for 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Modified Training Group

ACTIVE COMPARATOR

It is a training program that will be carried out under the supervision of a physiotherapist. There will be 3-minute breaks between sets. A training program will be applied to the athletes based on revising the training program they use in their routine with eccentric contractions.

Other: Modified Training Programme

Routine Training Group

ACTIVE COMPARATOR

The training program that the athlete uses in her normal routine will be implemented under the supervision of a physiotherapist.

Other: Routine Training Programme

Interventions

Eccentric muscle contractions and 3-minute rest breaks will be used.

Modified Training Group

A routine training program will be used.

Routine Training Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWoman
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old female gender
  • Body mass index being less than 18.50-24.99 kg/m2
  • Having a energy deficiency
  • Been interested in basketball professionally for at least one year
  • Must be training with the team at least 3 days a week
  • Performance levels should be 3-4

You may not qualify if:

  • Having a history of any fracture in the last year
  • Having had a sports injury in the last 8 months
  • Having had an infectious disease in the last 6 months being a smoker
  • Getting 2 or more points from the SCOFF survey
  • Having been using any medication regularly for the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (9)

  • 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 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
  • De Souza MJ, Nattiv A, Joy E, Misra M, Williams NI, Mallinson RJ, Gibbs JC, Olmsted M, Goolsby M, Matheson G; Female Athlete Triad Coalition; American College of Sports Medicine; American Medical Society for Sports Medicine; American Bone Health Alliance. 2014 Female Athlete Triad Coalition consensus statement on treatment and return to play of the female athlete triad: 1st International Conference held in San Francisco, CA, May 2012, and 2nd International Conference held in Indianapolis, IN, May 2013. Clin J Sport Med. 2014 Mar;24(2):96-119. doi: 10.1097/JSM.0000000000000085.

    PMID: 24569429BACKGROUND
  • Loucks AB, Stachenfeld NS, DiPietro L. The female athlete triad: do female athletes need to take special care to avoid low energy availability? Med Sci Sports Exerc. 2006 Oct;38(10):1694-700. doi: 10.1249/01.mss.0000239397.01203.83. No abstract available.

    PMID: 17019289BACKGROUND
  • Heikura IA, Burke LM, Bergland D, Uusitalo ALT, Mero AA, Stellingwerff T. Impact of Energy Availability, Health, and Sex on Hemoglobin-Mass Responses Following Live-High-Train-High Altitude Training in Elite Female and Male Distance Athletes. Int J Sports Physiol Perform. 2018 Sep 1;13(8):1090-1096. doi: 10.1123/ijspp.2017-0547. Epub 2018 Sep 13.

    PMID: 29431548BACKGROUND
  • Joy E, De Souza MJ, Nattiv A, Misra M, Williams NI, Mallinson RJ, Gibbs JC, Olmsted M, Goolsby M, Matheson G, Barrack M, Burke L, Drinkwater B, Lebrun C, Loucks AB, Mountjoy M, Nichols J, Borgen JS. 2014 female athlete triad coalition consensus statement on treatment and return to play of the female athlete triad. Curr Sports Med Rep. 2014 Jul-Aug;13(4):219-32. doi: 10.1249/JSR.0000000000000077.

    PMID: 25014387BACKGROUND
  • Joy E, Kussman A, Nattiv A. 2016 update on eating disorders in athletes: A comprehensive narrative review with a focus on clinical assessment and management. Br J Sports Med. 2016 Feb;50(3):154-62. doi: 10.1136/bjsports-2015-095735.

    PMID: 26782763BACKGROUND
  • Elliott-Sale KJ, Tenforde AS, Parziale AL, Holtzman B, Ackerman KE. Endocrine Effects of Relative Energy Deficiency in Sport. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):335-349. doi: 10.1123/ijsnem.2018-0127. Epub 2018 Jul 14.

    PMID: 30008240BACKGROUND
  • 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

MeSH Terms

Conditions

Female Athlete Triad Syndrome

Condition Hierarchy (Ancestors)

Relative Energy Deficiency in SportFeeding and Eating DisordersMental Disorders

Central Study Contacts

Ayşenur Erekdağ, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The investigator administering the treatment and the investigator performing the evaluations will be different. The evaluator will not know about the interventions that the participants received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 23, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations