Low Energy AvailabilityTriatLEANCT07232628
Energy Availability and Its Impact in Elite Triathletes
An observational study of Low Energy Availability and Relative Energy Deficiency in Sport, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
This study investigates how energy availability affects performance, injury risk, and training outcomes in elite triathletes. Over two competitive seasons (2026-2027), 40 elite and sub-elite triathletes will be monitored through physiological tests, blood samples, and questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Energy Availability, Relative Energy Deficiency in Sport
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2025to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elite triathletes with a weekly training volume of more than 15 hours
Who may be able to join
- Age ≥18 years
- Healthy individuals
- Training ≥15 hours/week in triathlon
Who cannot join
- Smokers
- Use of prohibited substances (WADA list) without medical justification
- Existing injuries or illnesses that could worsen due to participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen
Jakob Agergaard, Ph.D., +45 38 63 58 73, jakob.agergaard@regionh.dk
About this study
Official title: Energy Availability in Elite Triathletes: Impact on Performance and Injury Risk
This study investigates how energy availability affects performance, injury risk, and training outcomes in elite triathletes. Over two competitive seasons (2026-2027), 40 elite and sub-elite triathletes will be monitored through physiological tests, blood samples, and questionnaires. The goal is to identify markers of low energy availability and understand its impact on health and athletic performance. The study is observational and does not involve experimental treatments. Participants continue their regular training and diet while undergoing periodic assessments.
Read the detailed description
Low energy availability (LEA) is a condition where the energy intake of an athlete is insufficient to support both training demands and essential physiological functions. LEA is common among endurance athletes, including triathletes, due to high training volumes and sometimes intentional dietary restrictions. Prolonged LEA can lead to hormonal imbalances, impaired bone health, reduced immune function, and increased injury risk. This study aims to explore the prevalence and consequences of LEA in elite triathletes over two seasons.
The study is a 2-year exploratory cohort study conducted at the Institute of Sports Medicine, Bispebjerg Hospital, Copenhagen. Forty elite or sub-elite triathletes (men and women, aged 18+) who train more than 15 hours per week will be enrolled. Participants will undergo five comprehensive test days spaced across the off-season, pre-season, and in-season periods of 2025-2027. These test days include blood sampling, DXA scans, MR imaging, muscle strength and stiffness assessments, VO₂ max testing, and dietary and activity monitoring.
The primary outcome is the change in the thyroid hormone triiodothyronine (T3), a known marker of LEA. Secondary outcomes include bone density, muscle mass, metabolic rate, performance metrics (e.g., running economy, VO₂ max), and injury incidence. Energy availability will be assessed via validated questionnaires (LEAF-Q for females, LEAM-Q for males), dietary logs (MyFood24), and training data from wearable devices.
Monthly injury reports and quarterly dietary assessments will be collected. Blood samples will be analyzed for hormones (e.g., cortisol, testosterone, GH, IGF-1, TSH, T3, T4), bone turnover markers (CTX, PINP, osteocalcin), immune parameters, and nutritional status (e.g., vitamin D, iron, B12). Some samples will be stored in a coded biobank until 2029 for future analysis.
Participants will receive no financial compensation but will be reimbursed for public transport. All procedures are non-invasive or minimally invasive and carry low risk. The study has been approved by the relevant ethics committee (Approval No. H-25043062), and informed consent will be obtained from all participants.
Results will be published in peer-reviewed journals and presented at scientific conferences. If not accepted for publication, results will be made publicly available via ClinicalTrials.gov and the EU Clinical Trials Register.
- Keywords
- RED-S, injury risk, performance, triathlon, biomarker
- Medical subject headings
- Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Triathletes | Elite triathletes |
What is being measured
The primary outcome is the main question the study is designed to answer.
T3
Plasma triiodothyronine (T3) levels
Measured: Two years - from off-season 2025 until in-season 2027
Secondary outcomes (22)
RER
Resting energy expenditure by indirect calorimetry
Measured: Two years - from off-season 2025 until in-season 2027
Bone mineral density
Bone mineral density by DXA scanning
Measured: Two years - from off-season 2025 until in-season 2027
Fat free mass
Fat free mass by DXA scanning
Measured: Two years - from off-season 2025 until in-season 2027
Appendicular fat free mass
Appendicular fat free mass by DXA scanning
Measured: Two years - from off-season 2025 until in-season 2027
Fat mass
Fat mass by DXA scanning
Measured: Two years - from off-season 2025 until in-season 2027
Tendon thickness
Patella and Achilles tendon thickness by ultrasound
Measured: Two years - from off-season 2025 until in-season 2027
Tendon vascularisation
Color doppler by ultrasound of Patella and Achilles tendons
Measured: Two years - from off-season 2025 until in-season 2027
Tendon stiffness
Patella and Achilles tendon stiffness by MyotonPro measurement
Measured: Two years - from off-season 2025 until in-season 2027
Quadriceps muscle strength
Concentric muscle strength by Biodex dynamometer
Measured: Two years - from off-season 2025 until in-season 2027
Hamstring muscle strength
Concentric muscle strength by Biodex dynamometer
Measured: Two years - from off-season 2025 until in-season 2027
Peak muscle power
Measured during counter movement jump on force-plate
Measured: Two years - from off-season 2025 until in-season 2027
Jump height
Measured during counter movement jump on force-plate
Measured: Two years - from off-season 2025 until in-season 2027
Running economy
Measured on treadmill with direct measurement of oxygen uptake
Measured: Two years - from off-season 2025 until in-season 2027
Biking economy
Measured on ergometer bike with direct measurement of oxygen uptake
Measured: Two years - from off-season 2025 until in-season 2027
Maximal oxygen uptake
Measured on ergometer bike with direct measurement of oxygen uptake
Measured: Two years - from off-season 2025 until in-season 2027
Calorie intake
Measured on three-day dietary registrations
Measured: Two years - from off-season 2025 until in-season 2027
Exercise energy expenditure
Measured by tracking devices
Measured: Two years - from off-season 2025 until in-season 2027
Risk of low energy availability
Evaluated by questionnaires - LEAF-Q for females, and LEAM-Q for males
Measured: Two years - from off-season 2025 until in-season 2027
Risk of eating disorder
Evaluated by EDE-Q questionnaire
Measured: Two years - from off-season 2025 until in-season 2027
Injury prevalence
Evaluated through monthly injury diary
Measured: Two years - from off-season 2025 until in-season 2027
Time loss due to injuries
Evaluated through monthly injury diary
Measured: Two years - from off-season 2025 until in-season 2027
Biomarkers
Biomarkers related to metabolism, stress hormones, sex hormones, immune system, muscle breakdown, organ function, bone turnover, lipid profile, minerals, haemoglobin and iron status measured from blood samples
Measured: Two years - from off-season 2025 until in-season 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Oct 2025
- Primary completion30 Nov 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Energy AvailabilityStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Agergaard, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232628
- Sponsor's protocol ID
- BBH171
- Other IDs
- H-25043062
- Acronym
- TriatLEA
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Availability in Elite Triathletes: Impact on Performance and Injury Risk
- ClinicalTrials.gov ID
- NCT07232628
- Acronym / sponsor ID
- TriatLEA / BBH171
- Keywords
- RED-S, injury risk, performance, triathlon, biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Nov 2025 (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.
This study investigates how energy availability affects performance, injury risk, and training outcomes in elite triathletes. Over two competitive seasons (2026-2027), 40 elite and sub-elite triathletes will be monitored through physiological tests, blood samples, and questionnaires. The goal is to identify markers of low energy availability and understand its impact on health and athletic performance. The study is observational and does not involve experimental treatments. Participants continue their regular training and diet while undergoing periodic assessments.
Detailed description
Low energy availability (LEA) is a condition where the energy intake of an athlete is insufficient to support both training demands and essential physiological functions. LEA is common among endurance athletes, including triathletes, due to high training volumes and sometimes intentional dietary restrictions. Prolonged LEA can lead to hormonal imbalances, impaired bone health, reduced immune function, and increased injury risk. This study aims to explore the prevalence and consequences of LEA in elite triathletes over two seasons.
The study is a 2-year exploratory cohort study conducted at the Institute of Sports Medicine, Bispebjerg Hospital, Copenhagen. Forty elite or sub-elite triathletes (men and women, aged 18+) who train more than 15 hours per week will be enrolled. Participants will undergo five comprehensive test days spaced across the off-season, pre-season, and in-season periods of 2025-2027. These test days include blood sampling, DXA scans, MR imaging, muscle strength and stiffness assessments, VO₂ max testing, and dietary and activity monitoring.
The primary outcome is the change in the thyroid hormone triiodothyronine (T3), a known marker of LEA. Secondary outcomes include bone density, muscle mass, metabolic rate, performance metrics (e.g., running economy, VO₂ max), and injury incidence. Energy availability will be assessed via validated questionnaires (LEAF-Q for females, LEAM-Q for males), dietary logs (MyFood24), and training data from wearable devices.
Monthly injury reports and quarterly dietary assessments will be collected. Blood samples will be analyzed for hormones (e.g., cortisol, testosterone, GH, IGF-1, TSH, T3, T4), bone turnover markers (CTX, PINP, osteocalcin), immune parameters, and nutritional status (e.g., vitamin D, iron, B12). Some samples will be stored in a coded biobank until 2029 for future analysis.
Participants will receive no financial compensation but will be reimbursed for public transport. All procedures are non-invasive or minimally invasive and carry low risk. The study has been approved by the relevant ethics committee (Approval No. H-25043062), and informed consent will be obtained from all participants.
Results will be published in peer-reviewed journals and presented at scientific conferences. If not accepted for publication, results will be made publicly available via ClinicalTrials.gov and the EU Clinical Trials Register.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triathletes | – | –Elite triathletes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elite triathletes with a weekly training volume of more than 15 hours
Key inclusion criteria (3 listed)
- Age ≥18 years
- Healthy individuals
- Training ≥15 hours/week in triathlon
Key exclusion criteria (3 listed)
- Smokers
- Use of prohibited substances (WADA list) without medical justification
- Existing injuries or illnesses that could worsen due to participation
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
T3
Time frame: Two years - from off-season 2025 until in-season 2027
Plasma triiodothyronine (T3) levels
22 secondary outcomes
RER
Time frame: Two years - from off-season 2025 until in-season 2027
Bone mineral density
Time frame: Two years - from off-season 2025 until in-season 2027
Fat free mass
Time frame: Two years - from off-season 2025 until in-season 2027
Appendicular fat free mass
Time frame: Two years - from off-season 2025 until in-season 2027
Fat mass
Time frame: Two years - from off-season 2025 until in-season 2027
Tendon thickness
Time frame: Two years - from off-season 2025 until in-season 2027
Tendon vascularisation
Time frame: Two years - from off-season 2025 until in-season 2027
Tendon stiffness
Time frame: Two years - from off-season 2025 until in-season 2027
Quadriceps muscle strength
Time frame: Two years - from off-season 2025 until in-season 2027
Hamstring muscle strength
Time frame: Two years - from off-season 2025 until in-season 2027
Peak muscle power
Time frame: Two years - from off-season 2025 until in-season 2027
Jump height
Time frame: Two years - from off-season 2025 until in-season 2027
Running economy
Time frame: Two years - from off-season 2025 until in-season 2027
Biking economy
Time frame: Two years - from off-season 2025 until in-season 2027
Maximal oxygen uptake
Time frame: Two years - from off-season 2025 until in-season 2027
Calorie intake
Time frame: Two years - from off-season 2025 until in-season 2027
Exercise energy expenditure
Time frame: Two years - from off-season 2025 until in-season 2027
Risk of low energy availability
Time frame: Two years - from off-season 2025 until in-season 2027
Risk of eating disorder
Time frame: Two years - from off-season 2025 until in-season 2027
Injury prevalence
Time frame: Two years - from off-season 2025 until in-season 2027
Time loss due to injuries
Time frame: Two years - from off-season 2025 until in-season 2027
Biomarkers
Time frame: Two years - from off-season 2025 until in-season 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Energy Availability and Relative Energy Deficiency in Sport, run by Bispebjerg Hospital at 1 site in Denmark.
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 3 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Agergaard, Ph.D. (+45 38 63 58 73, jakob.agergaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T3 (time frame: Two years - from off-season 2025 until in-season 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.