Low Energy Availability and Cardiovascular Disease

NCT06615388 | Recruiting

• 1 other identifier: 328540
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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). 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).

Conditions

Low Energy Availability; Cardiovascular Diseases

Keywords

low energy availability; Cardiovascular Diseases; Physically active females

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to measure the cardiovascular risk factors associated with LEA in trained to elite female athletes.

  1 year

Secondary Outcomes (1)

• The secondary outcome is to measure the DNA methylation characteristics of trained to elite-level female athletes?

  1 year

Study Arms (1)

Physically active females

Physically active females with and with low energy availability

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Anticoagulants users
• Pregnant women
• Volunteers on lipid-lowering medication
• Taking hormonal contraception (copper IUDs are acceptable)

Sponsors & Collaborators

• Liverpool Hope University: lead
• Oxford Brookes University: collaborator

Study Sites (1)

Liverpool Hope University

Liverpool, Merseyside, L16 9JD, United Kingdom

RECRUITING

Related Publications (11)

• 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.

  PMID: 32910256 BACKGROUND

• Mountjoy 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.

  PMID: 29771168 BACKGROUND

• Melin 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.

  PMID: 30632422 BACKGROUND

• McKay 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.

  PMID: 34965513 BACKGROUND

• Loucks 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.

  PMID: 9451615 BACKGROUND

• Kazmi 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.

  PMID: 31999706 BACKGROUND

• Elliott-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.

  PMID: 33725341 BACKGROUND

• De 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.

  PMID: 24463911 BACKGROUND

• Chilunga 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.

  PMID: 33890479 BACKGROUND

• Black 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.

  PMID: 29624522 BACKGROUND

• Areta 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.

  PMID: 33095376 BACKGROUND

Related Links

• THE CLINICAL IMPAIRMENT ASSESSMENT QUESTIONNAIRE (CIA)

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 26, 2024
• Study Start: September 10, 2024
• Primary Completion: December 13, 2025
• Study Completion: February 13, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)