Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615388
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Low Energy Availability and Cardiovascular Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Low Energy Availability and Cardiovascular Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Machine learning models will also be used to detect novel patterns of lipidsmetabolites 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 kJfat-free mass kg 5 Group allocation of participants will be based on the following classification Low risk of LEA High EA 45 kcalkg LBMd and high risk of LEA EA 30 kcalkg LBMd 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 participants39 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 participants39 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 studys results reliability
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
Machine learning models will also be used to detect novel patterns of lipidsmetabolites 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 kJfat-free mass kg 5 Group allocation of participants will be based on the following classification Low risk of LEA High EA 45 kcalkg LBMd and high risk of LEA EA 30 kcalkg LBMd 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 participants39 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 participants39 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 studys results reliability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None