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临床试验/NCT06615388
NCT06615388已完成不适用

Low Energy Availability and Cardiovascular Disease

Liverpool Hope University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
The primary outcome is to measure the cardiovascular risk factors associated with LEA in trained to elite female athletes.

研究概览

简要总结

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).

详细描述

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:

  1. Demographic data such as age, sports participation (training, competition duration, frequency etc.) and competitive level.
  2. Anthropometric data including height, body mass and DEXA scans.
  3. 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.
  4. 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.
  5. 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.
  6. Nutritional assessment via 5-day photographic food diaries, weighed food records along with a short interview to ensure accurate readings.
  7. 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.
  8. 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.
  9. Low energy availability test via the LEAF-Q (5) and calculation of LEA to check if participants are getting enough energy
  10. A questionnaire to assess menstrual cycle health, status, and hormonal contraception use
  11. 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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

结局指标

主要结局

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

时间窗: 1 year

次要结局

  • The secondary outcome is to measure the DNA methylation characteristics of trained to elite-level female athletes?(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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