An observational study in Vascular Stiffness, Hypertension (HTN) and Nutritional Deficiency Related Cardiovascular Risk in Athletes, sponsored by North Carolina Agriculture & Technical State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by North Carolina Agriculture & Technical State University · Observational
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.
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.
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This study's planned enrollment of 150 is below the median of 350 across 1,163 observational studies indexed under Hypertension.
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Men and women (n = 120, aged 18-26yrs) who are actively cleared to compete in division I sports at a historically black college or university. Participants will have at least 3yrs previous competitive experience. Participants will be recruited for testing once during the competitive season and once outside of the competitive season. The rationale for including these team Athletes is that the level of vigorous cardiovascular exercise training associated with these sports is significant and consistent.
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Age: 18-25yrs Sex: Male and Female Training Status/Experience: HBCU Division I collegiate athletes with >3yrs of previous competitive experience
Exclusion Criteria:
Excluded
Division I athletes with a minimum of \>3yrs experience tested once inside the competitive season and once outside of the competitive season beginning January 2026.
Pulse wave velocity (PWV)
Pulse wave velocity (PWV) will be calculated by dividing the arterial path length by the pulse transit time (PTT) between the brachial and femoral arteries using the Vicorder® AS Testing System (80Beats Medical, Berlin, DE). Using a custom-built caliper, arterial path length will be calculated as 80% of the straight-line distance between the brachial and femoral artery measurement sites. To measure PTT, blood pressure cuffs will be simultaneously inflated to a sub-diastolic pressure over a 10-15s period to acquire the foot of the proximal and distal pressure waveforms. The closest two of three recordings will be averaged.
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
Energy availability (EA) will be calculated as: EA = (EI - TDEE) / FFM, where EI is energy intake (kcal·day-¹), TDEE is total daily energy expenditure (kcal·day-¹), and FFM is fat-free mass (kg). TDEE will be estimated as the sum of resting metabolic rate (RMR) and activity-related energy expenditure. RMR (kcal·day-¹) will be measured via indirect calorimetry. Activity energy expenditure will be quantified using metabolic equivalents (METs), expressed as hours per day and converted to kilocalories. Energy intake (EI) will be assessed using 3-day nonconsecutive food records (two weekdays, one weekend day) to capture habitual variability while minimizing participant burden. To reduce reporting bias, records will be collected using dietitian-administered multiple-pass interviews, which improve accuracy relative to unassisted methods. Dietary data will be analyzed using Nutrition Data System for Research (NDSR; University of Minnesota).
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).
Social Determinants of Health (SDOH)
Four SDOH domains (Figure 3) will be assessed via validated questionnaires administered electronically through Qualtrics (Provo UT, USA). Built Environment/Food Security: using the USDA Food Access Research Atlas each participant's primary residence zip code will be geocoded to classify the food environment as: 1) food desert (low income + low access); 2) low access only; 3) adequate access.
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
Health Literacy: the 10-item Health Literacy Skills Instrument-Short Form (HLSI-SF) (score range: 0-50, higher scores indicate better 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
Sport Nutrition Knowledge: the 16-item Athlete Diet Index (ADI) will evaluate knowledge of nutrition. The summary score ranges between 0 (lowest knowledge) and 100 (highest 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
Discrimination: the 9-item Everyday Discrimination Scale will measure the frequency of discriminatory experiences in daily life (e.g., treated with less respect, receiving poorer service). Scores range from 9-54, with higher scores indicating greater exposure.
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).
Demographics
Age, sex, and race/ethnicity will be recorded using self report questionnaires.
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).
Plan to share: Undecided — Currently there are not plans to share individual data. However, data will be made available upon request in a de-identified capacity only.
Started Jan 2026 (actual). Primary completion is estimated for May 2027, 16 months after the start.
Of 345 non-industry observational studies under Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 111. This study's planned 16 months is below that.
Counting every sponsor, half of 426 studies reached it within 38 months; a quarter within 17 and three quarters within 96.
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North Carolina Agriculture & Technical State University