Vascular StiffnessCORE-DINCT07583940
Low Energy Availability and Hypertension in Division I HBCU Athletes
An observational study of Vascular Stiffness and Hypertension (HTN), run by North Carolina Agriculture & Technical State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Stiffness, Hypertension (HTN), Nutritional Deficiency Related Cardiovascular Risk in Athletes
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 30 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Age: 18-25yrs Sex: Male and Female Training Status/Experience: HBCU Division I collegiate athletes with >3yrs of previous competitive experience
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Carolina Agricultural & Technical State University
Greensboro, North Carolina, 27411
Troy M Purdom, PhD, 3362853552, tpurdom@ncat.edu
Catherine Bush, PhD, MPH, 336-334-7712, cmbush@ncat.edu
About this study
Official title: Cardiovascular Outcomes and Relative Energy Deficiency in Division I HBCU Athletes: CORE-DI Study
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.
Read the 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.
- Conditions
- Vascular Stiffness, Hypertension (HTN), Nutritional Deficiency Related Cardiovascular Risk in Athletes
- Keywords
- vascular stiffness,, hypertension, nutritional deficiency, energy balance, RED-S, SDOH
- Medical subject headings
- Hypertension, Malnutrition, Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Division I HBCU Athletes | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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 outcomes (4)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start6 Jan 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Vascular StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583940
- Sponsor's protocol ID
- R16HL179144-01
- Other IDs
- 1R16HL179144
- Acronym
- CORE-DI
- Status last verified
- May 2026
- First submitted
- 9 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently there are not plans to share individual data. However, data will be made available upon request in a de-identified capacity only.
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.
PubMed 16380565Snyder 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.
PubMed 30373688WEIR 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.
PubMed 15394301Williams 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.
PubMed 22013026Capling 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.
PubMed 33077018Bann 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.
PubMed 23030570McGreevy 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.
PubMed 23544457Stoner 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.
PubMed 31810627Yang YL, Yang HL, Kusuma JD, Shiao SPK. Validating Accuracy of an Internet-Based Application against USDA Computerized Nutrition Data System for Research on Essential Nutrients among Social-Ethnic Diets for the E-Health Era. Nutrients. 2022 Jul 31;14(15):3168. doi: 10.3390/nu14153168.
PubMed 35956344Shim JS, Oh K, Kim HC. Dietary assessment methods in epidemiologic studies. Epidemiol Health. 2014 Jul 22;36:e2014009. doi: 10.4178/epih/e2014009. eCollection 2014.
PubMed 25078382Havranek EP, Mujahid MS, Barr DA, Blair IV, Cohen MS, Cruz-Flores S, Davey-Smith G, Dennison-Himmelfarb CR, Lauer MS, Lockwood DW, Rosal M, Yancy CW; American Heart Association Council on Quality of Care and Outcomes Research, Council on Epidemiology and Prevention, Council on Cardiovascular and Stroke Nursing, Council on Lifestyle and Cardiometabolic Health, and Stroke Council. Social Determinants of Risk and Outcomes for Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 1;132(9):873-98. doi: 10.1161/CIR.0000000000000228. Epub 2015 Aug 3. No abstract available.
PubMed 26240271Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
PubMed 29133354Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Tsao CW, Urbut SM, Van Spall HGC, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Palaniappan LP; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2024 Feb 20;149(8):e347-e913. doi: 10.1161/CIR.0000000000001209. Epub 2024 Jan 24.
PubMed 38264914Purdom T, Cook M, Colleran H, Stewart P, San Diego L. Low Energy Availability (LEA) and Hypertension in Black Division I Collegiate Athletes: A Novel Pilot Study. Sports (Basel). 2023 Apr 7;11(4):81. doi: 10.3390/sports11040081.
PubMed 37104155Mountjoy M, Ackerman KE, Bailey DM, Burke LM, Constantini N, Hackney AC, Heikura IA, Melin A, Pensgaard AM, Stellingwerff T, Sundgot-Borgen JK, Torstveit MK, Jacobsen AU, Verhagen E, Budgett R, Engebretsen L, Erdener U. 2023 International Olympic Committee's (IOC) consensus statement on Relative Energy Deficiency in Sport (REDs). Br J Sports Med. 2023 Sep;57(17):1073-1097. doi: 10.1136/bjsports-2023-106994.
PubMed 37752011