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Low Energy Availability and Hypertension in Division I HBCU Athletes (CORE-DI)

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

150

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Troy M Purdom, PhD
  • 電話番号:13362853552
  • メール:tpurdom@ncat.edu

研究連絡先のバックアップ

  • 名前:Catherine Bush, PhD
  • 電話番号:3363347712
  • メール:cmbush@ncat.edu

研究場所

    • North Carolina
      • Greensboro、North Carolina、アメリカ、27411
        • 募集
        • North Carolina Agricultural & Technical State University
        • コンタクト:
        • コンタクト:
          • Catherine Bush, PhD, MPH
          • 電話番号:336-334-7712
          • メール:cmbush@ncat.edu

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pulse wave velocity (PWV)
時間枠: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).
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
時間枠: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 (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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Social Determinants of Health (SDOH)
時間枠: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).
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.
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
時間枠: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: the 10-item Health Literacy Skills Instrument-Short Form (HLSI-SF) (score range: 0-50, higher scores indicate better 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
時間枠: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: the 16-item Athlete Diet Index (ADI) will evaluate knowledge of nutrition. The summary score ranges between 0 (lowest knowledge) and 100 (highest 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
時間枠: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: 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.
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).

その他の成果指標

結果測定
メジャーの説明
時間枠
Demographics
時間枠: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).
Age, sex, and race/ethnicity will be recorded using self report questionnaires.
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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月6日

一次修了 (推定)

2027年5月30日

研究の完了 (推定)

2028年6月30日

試験登録日

最初に提出

2026年4月9日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月13日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

Currently there are not plans to share individual data. However, data will be made available upon request in a de-identified capacity only.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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