- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232628
Energy Availability and Its Impact in Elite Triathletes (TriatLEA)
Energy Availability in Elite Triathletes: Impact on Performance and Injury Risk
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jakob Agergaard, Ph.D.
- Phone Number: +45 38 63 58 73
- Email: jakob.agergaard@regionh.dk
Study Locations
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Copenhagen, Denmark
- Recruiting
- Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
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Contact:
- Jakob Agergaard, Ph.D.
- Phone Number: +45 38 63 58 73
- Email: jakob.agergaard@regionh.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Healthy individuals
- Training ≥15 hours/week in triathlon
Exclusion Criteria:
- Smokers
- Use of prohibited substances (WADA list) without medical justification
- Existing injuries or illnesses that could worsen due to participation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Triathletes
Elite triathletes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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T3
Time Frame: Two years - from off-season 2025 until in-season 2027
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Plasma triiodothyronine (T3) levels
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Two years - from off-season 2025 until in-season 2027
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RER
Time Frame: Two years - from off-season 2025 until in-season 2027
|
Resting energy expenditure by indirect calorimetry
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Two years - from off-season 2025 until in-season 2027
|
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Bone mineral density
Time Frame: Two years - from off-season 2025 until in-season 2027
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Bone mineral density by DXA scanning
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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
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Fat free mass by DXA scanning
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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
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Appendicular fat free mass by DXA scanning
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Two years - from off-season 2025 until in-season 2027
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Fat mass
Time Frame: Two years - from off-season 2025 until in-season 2027
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Fat mass by DXA scanning
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Two years - from off-season 2025 until in-season 2027
|
|
Tendon thickness
Time Frame: Two years - from off-season 2025 until in-season 2027
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Patella and Achilles tendon thickness by ultrasound
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Two years - from off-season 2025 until in-season 2027
|
|
Tendon vascularisation
Time Frame: Two years - from off-season 2025 until in-season 2027
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Color doppler by ultrasound of Patella and Achilles tendons
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Two years - from off-season 2025 until in-season 2027
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|
Tendon stiffness
Time Frame: Two years - from off-season 2025 until in-season 2027
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Patella and Achilles tendon stiffness by MyotonPro measurement
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Two years - from off-season 2025 until in-season 2027
|
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Quadriceps muscle strength
Time Frame: Two years - from off-season 2025 until in-season 2027
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Concentric muscle strength by Biodex dynamometer
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Two years - from off-season 2025 until in-season 2027
|
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Hamstring muscle strength
Time Frame: Two years - from off-season 2025 until in-season 2027
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Concentric muscle strength by Biodex dynamometer
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Two years - from off-season 2025 until in-season 2027
|
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Peak muscle power
Time Frame: Two years - from off-season 2025 until in-season 2027
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Measured during counter movement jump on force-plate
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Two years - from off-season 2025 until in-season 2027
|
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Jump height
Time Frame: Two years - from off-season 2025 until in-season 2027
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Measured during counter movement jump on force-plate
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Two years - from off-season 2025 until in-season 2027
|
|
Running economy
Time Frame: Two years - from off-season 2025 until in-season 2027
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Measured on treadmill with direct measurement of oxygen uptake
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Two years - from off-season 2025 until in-season 2027
|
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Biking economy
Time Frame: Two years - from off-season 2025 until in-season 2027
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Measured on ergometer bike with direct measurement of oxygen uptake
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Two years - from off-season 2025 until in-season 2027
|
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Maximal oxygen uptake
Time Frame: Two years - from off-season 2025 until in-season 2027
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Measured on ergometer bike with direct measurement of oxygen uptake
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Two years - from off-season 2025 until in-season 2027
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Calorie intake
Time Frame: Two years - from off-season 2025 until in-season 2027
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Measured on three-day dietary registrations
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Two years - from off-season 2025 until in-season 2027
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Exercise energy expenditure
Time Frame: Two years - from off-season 2025 until in-season 2027
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Measured by tracking devices
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Two years - from off-season 2025 until in-season 2027
|
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Risk of low energy availability
Time Frame: Two years - from off-season 2025 until in-season 2027
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Evaluated by questionnaires - LEAF-Q for females, and LEAM-Q for males
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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
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Evaluated by EDE-Q questionnaire
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Two years - from off-season 2025 until in-season 2027
|
|
Injury prevalence
Time Frame: Two years - from off-season 2025 until in-season 2027
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Evaluated through monthly injury diary
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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
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Evaluated through monthly injury diary
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Two years - from off-season 2025 until in-season 2027
|
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Biomarkers
Time Frame: Two years - from off-season 2025 until in-season 2027
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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
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Two years - from off-season 2025 until in-season 2027
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBH171
- H-25043062 (Other Identifier: The Regional Health Research Ethics Committees for the Capital Region of Denmark)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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