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Recruiting NCT07583940

Low Energy Availability and Hypertension in Division I HBCU Athletes

Observational Vascular Stiffness Hypertension (HTN) Nutritional Deficiency Related Cardiovascular Risk in Athletes

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Vascular Stiffness, Hypertension (HTN), Nutritional Deficiency Related Cardiovascular Risk in Athletes. Basic parameters: 18 years — 26 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Cardiovascular Outcomes and Relative Energy Deficiency in Division I HBCU Athletes: CORE-DI Study

Overview

Low energy availability (LEA) occurs when the body does not get enough calories to support both daily life and exercise. This can happen when athletes train hard but do not eat enough to match their energy needs. In both 2012 and 2023, the International Olympic Committee on Sports Nutrition recognized LEA as an important factor that can increase the risk of cardiometabolic disease (CMD), which includes conditions like high blood pressure, diabetes, and heart disease. LEA can affect many systems in the body. It may disrupt hormones (such as menstrual cycles), cause changes in blood sugar and cholesterol levels, weaken bones, impair digestion, and negatively impact mental health. Over time, these changes may be linked to chronic inflammation, which plays a key role in the development of disease. Maintaining proper energy balance can be especially challenging for athletes because they often train at levels well above general health recommendations. As a result, even highly fit athletes may unintentionally remain in a calorie deficit. Our recent pilot research found a significant relationship between LEA and high blood pressure in Black Division I collegiate athletes. This is important because this group has historically been understudied and may face a higher risk of serious heart-related events, including sudden cardiac death. Despite assumptions that collegiate athletes are uniformly healthy, there is a need to better understand hidden health risks in this population. Our research aims to improve how we identify and monitor early signs of cardiometabolic disease by examining markers such as inflammation, blood sugar, and cholesterol levels. These insights will help healthcare providers, athletes, and families make more informed decisions about nutrition, training, and long-term health. Ultimately, this work seeks to develop practical, evidence-based strategies to protect athlete health and reduce the risk of serious cardiovascular outcomes.

Detailed description

SPECIFIC AIMS: The International Olympic Committee on Sports Nutrition (IOCSN) recognized low energy availability (LEA), defined as inadequate calorie intake relative to energy expenditure. LEA may be particularly important cardiovascular disease (CVD) risk among minority athlete populations, especially those exposed to poor Social Determinants of Health (SDOH). This includes Black NCAA Division I collegiate athletes (BD1As), who make up 21% of the Division I population and have a 5x higher risk of sudden cardiac death compared to white athletes. Many of the SDOH indicators are alleviated as a Division I athlete (food is available, education support staff, economic stability, etc.). However, many BD1As come from areas described above and have limited awareness of nutritional factors that impact their health. Our pilot data indicate that BD1As with LEA, were over seven times (OR = 7.2) more likely to have hypertension. Further work is required to identify the mechanisms linking LEA to CVD. However, unraveling the mechanism's two gaps in the literature should be addressed: (i) establish whether the association between LEA and CVD risk is measurable; and (ii) determine whether the association between LEA and CVD is modifiable. Filling these gaps will make it possible to identify at-risk athletes and to prescribe strategies to restore energy balance (LEA) and/or directly decrease CVD risk.

Our long-term goal is to develop a practical, scalable, and effective non-pharmacological intervention to decrease LEA as a way to mitigate CVD risk in BD1As. To support this goal, the overall objective of this proposal is to robustly measure the strength of the association between LEA and HBP risk (in a larger cohort) and determine whether SDOH moderates this association. The investigators hypothesize that those identified as LEA will significantly increase CVD risk and therefore propose two specific aims. Aim 1 will test the hypothesis that LEA is positively associated with cardio-femoral pulse wave velocity (cfPWV), a measure of aortic arterial stiffness and the gold-standard biomarker of vascular aging. Aim 2 will test the hypothesis that LEA and cfPWV is moderated by SDOH. While SDOH research among BD1As does not exist, AAs are more likely to be deficient in fruits, vegetables while southern regions consume larger quantities of added fats, fried foods, processed meats, and sugar-sweetened beverages known to negatively impact cardiovascular health.

Completion of this work will help mitigate the empirical understanding that BD1As are \>7x more likely to experience HBP and 5x more likely to experience sudden cardiac death.

The proposed longitudinal observational study will recruit a cohort of \>120 BD1As aged 18-25 years recruited from various sports that include an equitable male/female population from a large HBCU. Participants will be assessed twice, \~4 months apart contingent on the beginning and end of their respective competitive season. For each assessment, traditional (nutrition) and novel (pulse wave velocity) CVD risk biomarkers will be measured, then questionnaires will collect information on SDOH: (i) built environment/food security (e.g. accessibility to food); (ii) health literacy (e.g.: ability to find/understand, use health related information); (iii) sport nutrition knowledge (e.g. knowledge of energy and nutrients); (iv) discrimination (e.g.: social/community context).

Aim 1. Determine the strength of the association between LEA and increased cfPWV. The strength of the association using a general linear model the investigators hypothesize that LEA will be strongly associated with cfPWV increase across the competitive season. Measuring cfPWV evaluates the velocity of the pulse wave or forward pressure transmitted between the carotid and femoral arteries. Decreased compliance of the aortic artery increases the velocity of the pulse wave and is known as arterial stiffness. Arterial stiffness is significantly associated with CVD risk and all cause death. cfPWV is known as the gold standard to evaluate arterial stiffness. The investigators predict that LEA will increase cfPWV by \>1 m/s increasing CVD risk by 14%.

Aim 2. Determine if the association between LEA and cfPWV is moderated by SDOH. The 4 SDOH variables will be added as covariates to the Aim 1 model independently and then in a multivariable model to test the strength of association between variables. Questionnaires will evaluate information related to: (i) built environment/food security by accessing published public demographic information/geomapping; (ii) health literacy skills instrument short form; (iii) sport nutrition knowledge using the athlete diet index; (iv) discrimination with the everyday discrimination scale. Three of the domains are shown to significantly affect health outcomes in AAs while poor sport nutrition knowledge is highly related to eating disorders and physiological dysfunction. The investigators predict that each SDOH will be a significant effect moderator to the LEA/cfPWV association.

Impact. PWV is a highly sensitive and continuous measure of vascular aging and the gold-stand non-invasive biomarker of CVD risk that has never been applied to BD1As. The final product will be an evidence-based reduction intervention to target LEA related CVD risk. Several factors increase the likelihood of high impact: established relationship with college athlete sample pool, and applicability to the larger athletic population, and our multi-disciplinary team and novel approach.

Primary outcome measures

  • Pulse wave velocity (PWV) [Time frame: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).]
  • Energy availability [Time frame: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).]
Secondary outcome measures (4)
  • Social Determinants of Health (SDOH) [Time frame: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).]
  • Health Literacy [Time frame: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).]
  • Sport Nutrition Knowledge [Time frame: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).]
  • Discrimination [Time frame: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).]

Eligibility criteria

Inclusion criteria

Age: 18-25yrs Sex: Male and Female Training Status/Experience: HBCU Division I collegiate athletes with >3yrs of previous competitive experience

Exclusion criteria

  • Persons who self-report any known disease, or unknown issue precluding collegiate competitive participation: Excluded
  • Those who have any orthopedic injuries, concussions, or conditions which would preclude safe testing: Excluded
  • Individuals who are not yet adults <18yrs (e.g.: infants, children, teenagers):

Excluded

  • Persons who have a pacemaker: Excluded
  • Persons who are pregnant: Excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • North Carolina Agricultural & Technical State University — Greensboro

Publications

  • Geronimus AT, Hicken M, Keene D, Bound J. "Weathering" and age patterns of allostatic load scores among blacks and whites in the United States. Am J Public Health. 2006 May;96(5):826-33. doi: 10.2105/AJPH.2004.060749. Epub 2005 Dec 27. PMID 16380565
  • Snyder E, Cai B, DeMuro C, Morrison MF, Ball W. A New Single-Item Sleep Quality Scale: Results of Psychometric Evaluation in Patients With Chronic Primary Insomnia and Depression. J Clin Sleep Med. 2018 Nov 15;14(11):1849-1857. doi: 10.5664/jcsm.7478. PMID 30373688
  • WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available. PMID 15394301
  • Williams DR, Yan Yu, Jackson JS, Anderson NB. Racial Differences in Physical and Mental Health: Socio-economic Status, Stress and Discrimination. J Health Psychol. 1997 Jul;2(3):335-51. doi: 10.1177/135910539700200305. PMID 22013026
  • Capling L, Gifford JA, Beck KL, Flood VM, Halar F, Slater GJ, O'Connor HT. Relative validity and reliability of a novel diet quality assessment tool for athletes: the Athlete Diet Index. Br J Nutr. 2021 Jul 28;126(2):307-319. doi: 10.1017/S000711452000416X. Epub 2020 Oct 20. PMID 33077018
  • Bann CM, McCormack LA, Berkman ND, Squiers LB. The Health Literacy Skills Instrument: a 10-item short form. J Health Commun. 2012;17 Suppl 3(Suppl 3):191-202. doi: 10.1080/10810730.2012.718042. PMID 23030570
  • McGreevy C, Barry M, Bennett K, Williams D. Repeatability of the measurement of aortic pulse wave velocity (aPWV) in the clinical assessment of arterial stiffness in community-dwelling older patients using the Vicorder((R)) device. Scand J Clin Lab Invest. 2013;73(4):269-73. doi: 10.3109/00365513.2013.770162. Epub 2013 Apr 2. PMID 23544457
  • Stoner L, Kucharska-Newton A, Meyer ML. Cardiometabolic Health and Carotid-Femoral Pulse Wave Velocity in Children: A Systematic Review and Meta-Regression. J Pediatr. 2020 Mar;218:98-105.e3. doi: 10.1016/j.jpeds.2019.10.065. Epub 2019 Dec 4. PMID 31810627

Identifiers

NCT: NCT07583940 · R16HL179144-01 · 1R16HL179144

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗