Female Athlete TriadNCT06220240
Energy Deficiency and Athletic Performance
A study testing Modified Training Programme and Routine Training Programme in people with Female Athlete Triad, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Female Athlete Triad
- What is being tested?
- Modified Training Programme and Routine Training Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2024to Dec 2025
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18- 35 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Modified Training Program Affect Energy Deficiency and Sportive Performance?
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.
Read more
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.
Read the detailed description
Voluntary participants who have been diagnosed with energy deficiency will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. Study groups will be as follows: a) Modified Training, b) Routine Training.
- Conditions
- Female Athlete Triad
- Being tested
- Modified Training Programme, Routine Training Programme
- Keywords
- Energy Deficiency, Eccentric Exercise, Athletic Performans
- Medical subject headings
- Female Athlete Triad Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Training ProgrammeOther
Eccentric muscle contractions and 3-minute rest breaks will be used.
Routine Training ProgrammeOther
A routine training program will be used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine Training Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 times for 2 weeks
Secondary outcomes (6)
Gonadotropin-Releasing Hormone Levels
Low energy availability is a condition that suppresses and disrupts hormonal function.
Measured: 3 times for 2 weeks
Adrenocorticotropic Hormone Levels
Low energy availability is a condition that suppresses and disrupts hormonal function.
Measured: 3 times for 2 weeks
thyroid stimulating Hormone Levels
Low energy availability is a condition that suppresses and disrupts hormonal function.
Measured: 3 times for 2 weeks
Luteinizing Hormone Levels
Low energy availability is a condition that suppresses and disrupts hormonal function.
Measured: 3 times for 2 weeks
Follicle-stimulating Hormone Levels
Low energy availability is a condition that suppresses and disrupts hormonal function.
Measured: 3 times for 2 weeks
Vertical Jump
The athlete will be positioned in a standing vertical position, with his feet shoulder-width apart. The athlete will reach the highest point he can in the vertec and this point will be considered the zero point. It will be asked to jump 3 times on a force plate to the highest level it can jump and the highest value will be recorded.
Measured: 3 times for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Female Athlete TriadStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Erekdag, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220240
- Sponsor's protocol ID
- 4203*929*
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21793767Mountjoy 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 29773536De 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.
PubMed 24569429Loucks 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.
PubMed 17019289Heikura 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.
PubMed 29431548Joy 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.
PubMed 25014387Joy 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.
PubMed 26782763Elliott-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.
PubMed 30008240Logue 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 32245088
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Modified Training Program Affect Energy Deficiency and Sportive Performance?
- ClinicalTrials.gov ID
- NCT06220240
- Acronym / sponsor ID
- 4203*929*
- Conditions
- Female Athlete Triad
- Keywords
- Energy Deficiency, Eccentric Exercise, Athletic Performans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2024 (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.
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.
Detailed description
Voluntary participants who have been diagnosed with energy deficiency will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. Study groups will be as follows: a) Modified Training, b) Routine Training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Training Group | Active comparator | Other: Modified Training ProgrammeIt 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. |
| Routine Training Group | Active comparator | Other: Routine Training ProgrammeThe training program that the athlete uses in her normal routine will be implemented under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18- 35 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Training ProgrammeEccentric muscle contractions and 3-minute rest breaks will be used. | Other | Modified Training Group |
| Routine Training ProgrammeA routine training program will be used. | Other | Routine Training Group |
Primary outcome
Energy Availability
Time frame: change from baseline pain at 2 weeks
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])"
Relative Energy Deficiency in Sports Clinical Assessment Tool (RED-S CAT)
Time frame: 3 times for 2 weeks
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.
Running Performance Analysis - Biomechanics
Time frame: 3 times for 2 weeks
Performance analysis will be performed on a 10-meter platform with DigitSole in order to evaluate the biomechanics.
Running Performance Analysis - Running Speed
Time frame: 3 times for 2 weeks
Performance analysis will be performed on a 10-meter platform with DigitSole in order to evaluate the running speed.
Running Performance Analysis - Economy of the Running
Time frame: 3 times for 2 weeks
Performance analysis will be performed on a 10-meter platform with DigitSole in order to evaluate the economy of the athlete's running activity.
6 secondary outcomes
Gonadotropin-Releasing Hormone Levels
Time frame: 3 times for 2 weeks
Adrenocorticotropic Hormone Levels
Time frame: 3 times for 2 weeks
thyroid stimulating Hormone Levels
Time frame: 3 times for 2 weeks
Luteinizing Hormone Levels
Time frame: 3 times for 2 weeks
Follicle-stimulating Hormone Levels
Time frame: 3 times for 2 weeks
Vertical Jump
Time frame: 3 times for 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- 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 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 24569429De 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.
- Background: PubMed 17019289Loucks 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.
- Background: PubMed 29431548Heikura 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.
- Background: PubMed 25014387Joy 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.
- Background: PubMed 26782763Joy 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.
- Background: PubMed 30008240Elliott-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.
- 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Training Programme and Routine Training Programme in people with Female Athlete Triad, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ayşenur Erekdağ, MSc (05548959013, aysenurerekdag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Availability (time frame: change from baseline pain at 2 weeks). The study lists 5 primary outcomes in all. 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 NCT06220240, which also lists 9 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 23 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.