Low Energy AvailabilityNCT06615388
Low Energy Availability and Cardiovascular Disease
An observational study of Low Energy Availability and Cardiovascular Diseases, run by Liverpool Hope University at 1 site in United Kingdom.
Trial summary
Low energy availability (LEA) signifies a condition where the body lacks sufficient energy to support essential physiological functions crucial for maintaining optimal health (1). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Energy Availability, Cardiovascular Diseases
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2024to 13 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: The team plans to include 126 trained to elite female athletes from local sports clubs near the Liverpool area to participate in the study.
Who may be able to join
- Cisgender females
- Aged 18 to 35 to avoid recruiting peri or postmenopausal females
- Trained to elite female athletes based on McKay and colleagues\' (2021) criteria for participation classification framework. For example, trained (local-level representation), highly trained (competing at the national level) and elite (competing at the international level).
- Females living in the United Kingdom.
Who cannot join
- Biological Males
- Females aged over 35
- Sedentary females
- Habitual smokers
- Volunteers with any previous experience with Syncope
- Volunteers with any previous diagnosis of ischaemic heart disease, myopathy or any neuromuscular disorder
Show all 10Show fewer
- Anticoagulants users
- Pregnant women
- Volunteers on lipid-lowering medication
- Taking hormonal contraception (copper IUDs are acceptable)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Hope University
Liverpool, Merseyside, L16 9JD
About this study
Low energy availability (LEA) signifies a condition where the body lacks sufficient energy to support essential physiological functions crucial for maintaining optimal health (1). This energy insufficiency can be exacerbated by the demands of sports and exercise, resulting in negative impacts on various physiological, psychological, and sports performance (11, 8, 2). While LEA is commonly associated with cardiovascular abnormalities, such as early atherosclerosis, endothelial dysfunction, and lower blood pressure, the existing body of research faces limitations, including small sample sizes and primarily exploratory approaches (2). Additionally, despite a growing body of evidence suggesting a strong link between DNA methylation (an epigenetic modification influencing gene expression by tagging specific parts of the DNA code) and cardiovascular disease (9, 6), there has been no prior investigation exploring the interplay between DNA methylation, cardiovascular disease, and LEA. To better understand LEA and its effects on cardiovascular health, it is imperative to address these limitations through further research. Utilising more comprehensive markers of cardiovascular disease and expanding the scope of investigations will contribute to a great understanding of LEA and its implications on cardiovascular health (10).
Read the detailed description
The team plans to include 126 trained to elite female athletes from local sports clubs near the Liverpool area to participate in the study.
Following ethical approval and informed consent from the participants, data will be collected during a one-time visit at Liverpool Hope University in one of the laboratories in the Health Science building.
Following a single laboratory visit, the following will be collected:
- Demographic data such as age, sports participation (training, competition duration, frequency etc.) and competitive level.
- Anthropometric data including height, body mass and DEXA scans.
- Genetic material (DNA) in cells collected from a buccal cheek smear swab test. Methylation analysis (study of cell function) on the buccal cells will be performed.
- Venous blood samples to determine hormonal profile. For example, measuring for Cholesterol, Lipids, C-reactive protein (CRP), full blood count , BNP (Natriuretic Peptide), Troponin, Oestrogen, GH (growth hormone), Ferritin, Iron studies, B12 and Folate, urea and electrolytes, Liver Function Tests, Calcium, Magnesium, Luteinising hormone, follicle stimulating hormone and sex hormone binding globulin, Prolactin, Cortisol, Progesterone, Testosterone, Insulin, Insulin-like Growth Factor, Thyroid-stimulating hormone, Thyroxine, Triiodothyronine, Creatine kinase and Vitamin D levels.
- Cardiovascular assessment to test heart and blood vessel health. For example, blood pressure, the stiffness of their arteries, and the thickness of blood vessel walls. Using assessments such as pulse wave velocity (PWV), Carotid Intima-Media Thickness Test (CIMT), Flow-mediated Dilation (FMD) and electrocardiogram (ECG). Pearson r correlation will be performed between Cardiovascular health and Low energy availability variables.
- Nutritional assessment via 5-day photographic food diaries, weighed food records along with a short interview to ensure accurate readings.
- Physical activity assessment with accelerometers for seven days to determine physical activity levels. The accelerometers will be dropped off and picked up after one week by the lead researcher, Mr Liam Pope.
- Eating behaviour and mood tests using the Eating Disorder Examination Questionnaire (EDE-Q) and the Clinical Impairment Assessment (CIA) (12) to assess their eating behaviours.
- Low energy availability test via the LEAF-Q (5) and calculation of LEA to check if participants are getting enough energy
- A questionnaire to assess menstrual cycle health, status, and hormonal contraception use
- Energy expenditure and resting metabolic rate assessment via indirect calorimetry to measure how much energy their bodies use and how much they burn at rest.
In addition, metabolomic analysis, lipoprotein subclass analysis and methylation analysis on blood cells will be performed.
Machine learning models will also be used to detect novel patterns of lipids/metabolites in the data. Multivariate analysis will be performed before the machine learning models.
Two groups will be formed, comprising one group identified as a high LEA risk group and the other as a low LEA risk group. LEA risk status will be established via the Loukes et al. (1999) equation: Energy availability = (Energy intake (kJ) - Energy expenditure during exercise (kJ))/fat-free mass (kg) (5). Group allocation of participants will be based on the following classification: Low risk of LEA High: EA ≥45 kcal/kg LBM/d and high risk of LEA EA 30 kcal/kg LBM/d (3).
To reduce the variability among the participant results concerning their menstrual cycle characteristics, all 126 selected volunteers will engage in a two-month menstrual cycle monitoring process before the testing for the main research study, following the methodological recommendations for female athlete research (7). This monitoring will occur in participants\' homes, utilising menstrual cycle tracking apps and ovulation testing kits that will be sent to them. To track menstrual cycles, volunteers will use a menstrual cycle tracking app to record the first and last day of menstruation for each cycle. Daily ovulation tests will also be conducted using urine to detect the mid-cycle surge in luteinising hormone. The occurrence of the mid-cycle surge in luteinizing hormone will be documented in the app, providing visual confirmation to the researcher. This will also serve as crucial information to identify each participant specific menstrual cycle phases.
To ensure consistent testing, the research team will schedule all participants\' tests for the main project during their early luteal phase, specifically in phase three. This phase captures a medium oestrogen concentration while keeping progesterone levels low, confirmed by a positive luteinizing hormone surge captured by the ovulation kit. This strategic choice is made to measure hormone levels within a normal range for health assessment, making it easier to identify any potential hormonal imbalances not due to the typical hormonal fluctuations linked with different phases of the menstrual cycle. This approach ensures precise timing aligned with specific menstrual phases that help minimise the impact of cycle-related variations to enhance the main study's results reliability.
- Conditions
- Low Energy Availability, Cardiovascular Diseases
- Keywords
- low energy availability, Cardiovascular Diseases, Physically active females
- Medical subject headings
- Cardiovascular Diseases
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 |
|---|---|---|
| Physically active females | Physically active females with and with low energy availability |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to measure the cardiovascular risk factors associated with LEA in trained to elite female athletes.
Measured: 1 year
Secondary outcomes (1)
The secondary outcome is to measure the DNA methylation characteristics of trained to elite-level female athletes?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start10 Sep 2024
- Primary completion13 Dec 2025
- Study completion13 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Liverpool Hope University
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615388
- Sponsor's protocol ID
- 328540
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participant data will be kept confidential in line with GDPR.
Publications
Wasserfurth P, Palmowski J, Hahn A, Kruger K. Reasons for and Consequences of Low Energy Availability in Female and Male Athletes: Social Environment, Adaptations, and Prevention. Sports Med Open. 2020 Sep 10;6(1):44. doi: 10.1186/s40798-020-00275-6.
PubMed 32910256Mountjoy M, Sundgot-Borgen J, Burke L, Ackerman KE, Blauwet C, Constantini N, Lebrun C, Lundy B, Melin A, Meyer N, Sherman R, Tenforde AS, Torstveit MK, Budgett R. International Olympic Committee (IOC) Consensus Statement on Relative Energy Deficiency in Sport (RED-S): 2018 Update. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):316-331. doi: 10.1123/ijsnem.2018-0136. Epub 2018 May 17. No abstract available.
PubMed 29771168Melin AK, Heikura IA, Tenforde A, Mountjoy M. Energy Availability in Athletics: Health, Performance, and Physique. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):152-164. doi: 10.1123/ijsnem.2018-0201. Epub 2019 Feb 26.
PubMed 30632422McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29.
PubMed 34965513Loucks AB, Verdun M, Heath EM. Low energy availability, not stress of exercise, alters LH pulsatility in exercising women. J Appl Physiol (1985). 1998 Jan;84(1):37-46. doi: 10.1152/jappl.1998.84.1.37.
PubMed 9451615Kazmi N, Elliott HR, Burrows K, Tillin T, Hughes AD, Chaturvedi N, Gaunt TR, Relton CL. Associations between high blood pressure and DNA methylation. PLoS One. 2020 Jan 30;15(1):e0227728. doi: 10.1371/journal.pone.0227728. eCollection 2020.
PubMed 31999706Elliott-Sale KJ, Minahan CL, de Jonge XAKJ, Ackerman KE, Sipila S, Constantini NW, Lebrun CM, Hackney AC. Methodological Considerations for Studies in Sport and Exercise Science with Women as Participants: A Working Guide for Standards of Practice for Research on Women. Sports Med. 2021 May;51(5):843-861. doi: 10.1007/s40279-021-01435-8. Epub 2021 Mar 16.
PubMed 33725341De Souza MJ, Nattiv A, Joy E, Misra M, Williams NI, Mallinson RJ, Gibbs JC, Olmsted M, Goolsby M, Matheson G; Expert Panel. 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, California, May 2012 and 2nd International Conference held in Indianapolis, Indiana, May 2013. Br J Sports Med. 2014 Feb;48(4):289. doi: 10.1136/bjsports-2013-093218.
PubMed 24463911Chilunga FP, Henneman P, Venema A, Meeks KA, Gonzalez JR, Ruiz-Arenas C, Requena-Mendez A, Beune E, Spranger J, Smeeth L, Bahendeka S, Owusu-Dabo E, Klipstein-Grobusch K, Adeyemo A, Mannens MM, Agyemang C. DNA methylation as the link between migration and the major noncommunicable diseases: the RODAM study. Epigenomics. 2021 May;13(9):653-666. doi: 10.2217/epi-2020-0329. Epub 2021 Apr 23.
PubMed 33890479Black K, Slater J, Brown RC, Cooke R. Low Energy Availability, Plasma Lipids, and Hormonal Profiles of Recreational Athletes. J Strength Cond Res. 2018 Oct;32(10):2816-2824. doi: 10.1519/JSC.0000000000002540.
PubMed 29624522Areta JL, Taylor HL, Koehler K. Low energy availability: history, definition and evidence of its endocrine, metabolic and physiological effects in prospective studies in females and males. Eur J Appl Physiol. 2021 Jan;121(1):1-21. doi: 10.1007/s00421-020-04516-0. Epub 2020 Oct 23.
PubMed 33095376
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Energy Availability and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06615388
- Acronym / sponsor ID
- 328540
- Conditions
- Low Energy Availability, Cardiovascular Diseases
- Keywords
- low energy availability, Cardiovascular Diseases, Physically active females
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Liverpool Hope UniversityUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 13 Dec 2025 (actual)
- Study completion
- 13 Dec 2025 (actual)
- First posted
- 26 Sep 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.
Low energy availability (LEA) signifies a condition where the body lacks sufficient energy to support essential physiological functions crucial for maintaining optimal health (1). This energy insufficiency can be exacerbated by the demands of sports and exercise, resulting in negative impacts on various physiological, psychological, and sports performance (11, 8, 2). While LEA is commonly associated with cardiovascular abnormalities, such as early atherosclerosis, endothelial dysfunction, and lower blood pressure, the existing body of research faces limitations, including small sample sizes and primarily exploratory approaches (2). Additionally, despite a growing body of evidence suggesting a strong link between DNA methylation (an epigenetic modification influencing gene expression by tagging specific parts of the DNA code) and cardiovascular disease (9, 6), there has been no prior investigation exploring the interplay between DNA methylation, cardiovascular disease, and LEA. To better understand LEA and its effects on cardiovascular health, it is imperative to address these limitations through further research. Utilising more comprehensive markers of cardiovascular disease and expanding the scope of investigations will contribute to a great understanding of LEA and its implications on cardiovascular health (10).
Detailed description
The team plans to include 126 trained to elite female athletes from local sports clubs near the Liverpool area to participate in the study.
Following ethical approval and informed consent from the participants, data will be collected during a one-time visit at Liverpool Hope University in one of the laboratories in the Health Science building.
Following a single laboratory visit, the following will be collected:
- Demographic data such as age, sports participation (training, competition duration, frequency etc.) and competitive level.
- Anthropometric data including height, body mass and DEXA scans.
- Genetic material (DNA) in cells collected from a buccal cheek smear swab test. Methylation analysis (study of cell function) on the buccal cells will be performed.
- Venous blood samples to determine hormonal profile. For example, measuring for Cholesterol, Lipids, C-reactive protein (CRP), full blood count , BNP (Natriuretic Peptide), Troponin, Oestrogen, GH (growth hormone), Ferritin, Iron studies, B12 and Folate, urea and electrolytes, Liver Function Tests, Calcium, Magnesium, Luteinising hormone, follicle stimulating hormone and sex hormone binding globulin, Prolactin, Cortisol, Progesterone, Testosterone, Insulin, Insulin-like Growth Factor, Thyroid-stimulating hormone, Thyroxine, Triiodothyronine, Creatine kinase and Vitamin D levels.
- Cardiovascular assessment to test heart and blood vessel health. For example, blood pressure, the stiffness of their arteries, and the thickness of blood vessel walls. Using assessments such as pulse wave velocity (PWV), Carotid Intima-Media Thickness Test (CIMT), Flow-mediated Dilation (FMD) and electrocardiogram (ECG). Pearson r correlation will be performed between Cardiovascular health and Low energy availability variables.
- Nutritional assessment via 5-day photographic food diaries, weighed food records along with a short interview to ensure accurate readings.
- Physical activity assessment with accelerometers for seven days to determine physical activity levels. The accelerometers will be dropped off and picked up after one week by the lead researcher, Mr Liam Pope.
- Eating behaviour and mood tests using the Eating Disorder Examination Questionnaire (EDE-Q) and the Clinical Impairment Assessment (CIA) (12) to assess their eating behaviours.
- Low energy availability test via the LEAF-Q (5) and calculation of LEA to check if participants are getting enough energy
- A questionnaire to assess menstrual cycle health, status, and hormonal contraception use
- Energy expenditure and resting metabolic rate assessment via indirect calorimetry to measure how much energy their bodies use and how much they burn at rest.
In addition, metabolomic analysis, lipoprotein subclass analysis and methylation analysis on blood cells will be performed.
Machine learning models will also be used to detect novel patterns of lipids/metabolites in the data. Multivariate analysis will be performed before the machine learning models.
Two groups will be formed, comprising one group identified as a high LEA risk group and the other as a low LEA risk group. LEA risk status will be established via the Loukes et al. (1999) equation: Energy availability = (Energy intake (kJ) - Energy expenditure during exercise (kJ))/fat-free mass (kg) (5). Group allocation of participants will be based on the following classification: Low risk of LEA High: EA ≥45 kcal/kg LBM/d and high risk of LEA EA 30 kcal/kg LBM/d (3).
To reduce the variability among the participant results concerning their menstrual cycle characteristics, all 126 selected volunteers will engage in a two-month menstrual cycle monitoring process before the testing for the main research study, following the methodological recommendations for female athlete research (7). This monitoring will occur in participants\' homes, utilising menstrual cycle tracking apps and ovulation testing kits that will be sent to them. To track menstrual cycles, volunteers will use a menstrual cycle tracking app to record the first and last day of menstruation for each cycle. Daily ovulation tests will also be conducted using urine to detect the mid-cycle surge in luteinising hormone. The occurrence of the mid-cycle surge in luteinizing hormone will be documented in the app, providing visual confirmation to the researcher. This will also serve as crucial information to identify each participant specific menstrual cycle phases.
To ensure consistent testing, the research team will schedule all participants\' tests for the main project during their early luteal phase, specifically in phase three. This phase captures a medium oestrogen concentration while keeping progesterone levels low, confirmed by a positive luteinizing hormone surge captured by the ovulation kit. This strategic choice is made to measure hormone levels within a normal range for health assessment, making it easier to identify any potential hormonal imbalances not due to the typical hormonal fluctuations linked with different phases of the menstrual cycle. This approach ensures precise timing aligned with specific menstrual phases that help minimise the impact of cycle-related variations to enhance the main study's results reliability.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physically active females | – | –Physically active females with and with low energy availability |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The team plans to include 126 trained to elite female athletes from local sports clubs near the Liverpool area to participate in the study.
Key inclusion criteria (4 listed)
- Cisgender females
- Aged 18 to 35 to avoid recruiting peri or postmenopausal females
- Trained to elite female athletes based on McKay and colleagues\' (2021) criteria for participation classification framework. For example, trained (local-level representation), highly trained (competing at the national level) and elite (competing at the international level).
- Females living in the United Kingdom.
Key exclusion criteria (10 listed)
- Biological Males
- Females aged over 35
- Sedentary females
- Habitual smokers
- Volunteers with any previous experience with Syncope
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
The primary outcome is to measure the cardiovascular risk factors associated with LEA in trained to elite female athletes.
Time frame: 1 year
1 secondary outcome
The secondary outcome is to measure the DNA methylation characteristics of trained to elite-level female athletes?
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 32910256Wasserfurth P, Palmowski J, Hahn A, Kruger K. Reasons for and Consequences of Low Energy Availability in Female and Male Athletes: Social Environment, Adaptations, and Prevention. Sports Med Open. 2020 Sep 10;6(1):44. doi: 10.1186/s40798-020-00275-6.
- Background: PubMed 29771168Mountjoy M, Sundgot-Borgen J, Burke L, Ackerman KE, Blauwet C, Constantini N, Lebrun C, Lundy B, Melin A, Meyer N, Sherman R, Tenforde AS, Torstveit MK, Budgett R. International Olympic Committee (IOC) Consensus Statement on Relative Energy Deficiency in Sport (RED-S): 2018 Update. Int J Sport Nutr Exerc Metab. 2018 Jul 1;28(4):316-331. doi: 10.1123/ijsnem.2018-0136. Epub 2018 May 17. No abstract available.
- Background: PubMed 30632422Melin AK, Heikura IA, Tenforde A, Mountjoy M. Energy Availability in Athletics: Health, Performance, and Physique. Int J Sport Nutr Exerc Metab. 2019 Mar 1;29(2):152-164. doi: 10.1123/ijsnem.2018-0201. Epub 2019 Feb 26.
- Background: PubMed 34965513McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29.
- Background: PubMed 9451615Loucks AB, Verdun M, Heath EM. Low energy availability, not stress of exercise, alters LH pulsatility in exercising women. J Appl Physiol (1985). 1998 Jan;84(1):37-46. doi: 10.1152/jappl.1998.84.1.37.
- Background: PubMed 31999706Kazmi N, Elliott HR, Burrows K, Tillin T, Hughes AD, Chaturvedi N, Gaunt TR, Relton CL. Associations between high blood pressure and DNA methylation. PLoS One. 2020 Jan 30;15(1):e0227728. doi: 10.1371/journal.pone.0227728. eCollection 2020.
- Background: PubMed 33725341Elliott-Sale KJ, Minahan CL, de Jonge XAKJ, Ackerman KE, Sipila S, Constantini NW, Lebrun CM, Hackney AC. Methodological Considerations for Studies in Sport and Exercise Science with Women as Participants: A Working Guide for Standards of Practice for Research on Women. Sports Med. 2021 May;51(5):843-861. doi: 10.1007/s40279-021-01435-8. Epub 2021 Mar 16.
- Background: PubMed 24463911De Souza MJ, Nattiv A, Joy E, Misra M, Williams NI, Mallinson RJ, Gibbs JC, Olmsted M, Goolsby M, Matheson G; Expert Panel. 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, California, May 2012 and 2nd International Conference held in Indianapolis, Indiana, May 2013. Br J Sports Med. 2014 Feb;48(4):289. doi: 10.1136/bjsports-2013-093218.
- Background: PubMed 33890479Chilunga FP, Henneman P, Venema A, Meeks KA, Gonzalez JR, Ruiz-Arenas C, Requena-Mendez A, Beune E, Spranger J, Smeeth L, Bahendeka S, Owusu-Dabo E, Klipstein-Grobusch K, Adeyemo A, Mannens MM, Agyemang C. DNA methylation as the link between migration and the major noncommunicable diseases: the RODAM study. Epigenomics. 2021 May;13(9):653-666. doi: 10.2217/epi-2020-0329. Epub 2021 Apr 23.
- Background: PubMed 29624522Black K, Slater J, Brown RC, Cooke R. Low Energy Availability, Plasma Lipids, and Hormonal Profiles of Recreational Athletes. J Strength Cond Res. 2018 Oct;32(10):2816-2824. doi: 10.1519/JSC.0000000000002540.
- Background: PubMed 33095376Areta JL, Taylor HL, Koehler K. Low energy availability: history, definition and evidence of its endocrine, metabolic and physiological effects in prospective studies in females and males. Eur J Appl Physiol. 2021 Jan;121(1):1-21. doi: 10.1007/s00421-020-04516-0. Epub 2020 Oct 23.
- THE CLINICAL IMPAIRMENT ASSESSMENT QUESTIONNAIRE (CIA)Link provided by the sponsor.
- Individual participant dataSharing planned: No. All participant data will be kept confidential in line with GDPR.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiovascular Diseases, run by Liverpool Hope University at 1 site in United Kingdom.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 17 Jun 2026. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to measure the cardiovascular risk factors associated with LEA in trained to elite female athletes. (time frame: 1 year). 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 NCT06615388, which also lists 11 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 17 Jun 2026.