An interventional study of Low Energy Availability Screening and Nutrition Support in Athlete, Relative Energy Deficiency in Sport and Low Energy Availability, sponsored by Case Western Reserve University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Other
The goal is to improve nutrition screening and support for Division III athletes.
The study will use standard, low-risk nutrition screening methods, such as measuring height, weight, grip strength, and body composition, as well as having athletes complete questionnaires. Dietitians trained in sports nutrition will provide nutrition advice based on these screenings.
Data will be collected at three points during the season: before the season starts, mid-season, and after the season ends. This study builds on earlier research conducted at Case Western Reserve University that showed nutrition support can improve athletes' health and performance.
OBJECTIVES: Combat student athletes' under fueling before, during and after the competitive season and assess financial feasibility for scaling to the university level.
STUDY OVERVIEW: This project proposes an open label, pilot research endeavor between the Department of Nutrition at Case Western Reserve University (CWRU), Pennington Biomedical Research Center (PBRC) and the NCAA Division III CWRU Athletic Department. The proposed study design will implement improved nutrition screening and support, applying standard-of-practice processes that are used at the highest level of collegiate sport (Division I) modified for the Division III athlete. This study will utilize minimal-risk/standard-of-care nutrition screening procedures along with standard-of-care nutrition advice from dietitians trained in sports nutrition. All athletes will be screened with minimal risk items such as anthropometrics, questionnaires, grip strength and body composition testing. While additional voluntary metrics will be provided in a subset of individuals based on team and individual availability and include aerobic fitness (VO2), resting metabolic rate, physical activity, body composition and sports performance. Data will be collected at three timepoints: pre-season, mid-season, and post-season. Notably, this work expands upon the investigators' prior pilot study that showed nutrition support improved athlete health and performance metrics. This study has streamlined the protocol and transition to standard-of-care nutrition support to improve scalability and reduce risk to participants.
GENERAL AIMS/HYPOTHESIS: This research program will evidence the importance of nutrition to improve athlete health and performance in Division III athletes. The investigators hypothesize that nutrition screening and support will improve athlete health and performance metrics. As a feasibility study, the primary aim is to assess the feasibility of scaling this nutrition support to a larger student athlete population than the first pilot trial (estimated 100-200 athletes compared to the original 27 from the pilot study). The investigators will assess feasibility from both logistic and financial perspectives. Secondary aims include athlete health and wellness metrics, such as body composition, strength, and health and wellness questionnaires, involving body image, injuries, energy levels and other important mental and physical factors.
20 studies on the registry are indexed under Relative Energy Deficiency in Sport; 10 are open to participants now.
This study's planned enrollment of 300 is above the median of 50 across 11 interventional studies indexed under Relative Energy Deficiency in Sport.
Browse Relative Energy Deficiency in Sport studies →Case Western Reserve University is the lead sponsor of 158 studies on the registry; 29 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Low Energy Availability Screening and Nutrition Support
Athletes will receive screening for low energy availability, strength and body composition assessments and receive nutrition support from a sports dietitian over the competitive season.
Grip Strength
Grip force in kilograms determined by a handgrip dynamometer, conducted on both arms, according to standard practice procedures.
Time frame: Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Low Energy Availability in Females Questionnaire (LEAF -Q)
Female participants only. Focuses on physiological symptoms of insufficient energy intake. includes 25 questions arranged in three separate, sequential sections: injuries, gastrointestinal, and reproductive functions. (score; 0-36; total score ≥8 is to be considered at risk)
Time frame: Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Low Energy Availability in Males Questionnaire (LEAM -Q)
The low energy availability in males questionnaire (LEAM -Q), focuses on physiological symptoms of relative energy deficiency. Categories include dizziness, gastrointestinal function, thermoregulation at rest, health problems, and recovery. The questionnaire also focuses on physiological symptoms of relative energy deficiency. A higher total score indicates a greater risk of low energy availability. Precise scoring cutoffs are not yet defined.
Time frame: Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Body Composition - Fat Mass
Fat mass (kilograms) and as a percent of total body mass.
Time frame: Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Body Composition - Fat Free Mass
Fat Free Mass (kilograms) and expressed as a percent of total body mass.
Time frame: Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Eating Disorder Examination Questionnaire (EDE-Q)
Measures eating disorder psychopathology. It provides a measure of the range and severity of eating disorder features. (score; continuous beginning at 0; a higher score means greater risk)
Time frame: Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Contextual Body Image Questionnaire for Athletes (CBIQA)
Measures four dimensions of body image (Appearance (3 questions), Body Shape (3 questions), Muscularity (3 questions) and Body Weight and Fat (5 questions)) in the context of both athletics and daily life. (7-point Likert scale for each question; scaled scores for each of the four dimensions are obtained by dividing the sum of each question score within that dimension divided by the number of questions in that dimension; scoring is relative to each question with a score of 4 being neutral)
Time frame: Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Muscle Dysmorphic Disorder Inventory (MDDI)
The MDDI consists of 13 items addressing drive for size, appearance intolerance, and functional impairment, and serves as a screening tool for muscularity concerns and muscle dysmorphia. Based on a 5-point likert scale. A higher score indicates greater risk for Muscle Dysmorphic Disorder.
Time frame: Baseline/Pre-season (August 2025), Mid-season (~2 months after baseline; October 2025), End of Study/End of Competitive Season (~4 months after baseline; December 2025)
Plan to share: Yes — Data will be shared upon reasonable request, with appropriate data sharing agreements in place, and according to institutional policy.
Supporting information: Study protocol, Sap, Icf
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