NCT07583940

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Jun 2028

Study Start

First participant enrolled

January 6, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

April 9, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

vascular stiffness,hypertensionnutritional deficiencyenergy balanceRED-SSDOH

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    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)

    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

    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

    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

    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).

Other Outcomes (1)

  • Demographics

    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).

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Agricultural & Technical State University

Greensboro, North Carolina, 27411, United States

RECRUITING

Related Publications (15)

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    PMID: 16380565BACKGROUND
  • 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.

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    PMID: 15394301BACKGROUND
  • 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: 22013026BACKGROUND
  • 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: 33077018BACKGROUND
  • 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: 23030570BACKGROUND
  • 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: 23544457BACKGROUND
  • 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: 31810627BACKGROUND
  • Yang 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.

    PMID: 35956344BACKGROUND
  • Shim 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.

    PMID: 25078382BACKGROUND
  • Havranek 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.

    PMID: 26240271BACKGROUND
  • Whelton 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.

    PMID: 29133354BACKGROUND
  • Martin 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.

    PMID: 38264914BACKGROUND
  • Purdom 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.

    PMID: 37104155BACKGROUND
  • Mountjoy 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.

    PMID: 37752011BACKGROUND

Related Links

MeSH Terms

Conditions

HypertensionMalnutritionRelative Energy Deficiency in Sport

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesNutrition DisordersNutritional and Metabolic DiseasesFeeding and Eating DisordersMental Disorders

Central Study Contacts

Troy M Purdom, PhD

CONTACT

Catherine Bush, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

May 13, 2026

Study Start

January 6, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations