Preventing Athlete Under-fueling Through Nutrition.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Energy Availability Screening and Nutrition Support.
- Who it may be relevant to
- Registry conditions: Athlete, Relative Energy Deficiency in Sport, Low Energy Availability. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevention and Education for RED-S Through Fueling Outcomes and Research in Metabolic Health
Overview
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.
Detailed description
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.
Interventions
- 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.
Primary outcome measures
- Grip Strength [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)]
Secondary outcome measures (7)
- Low Energy Availability in Females Questionnaire (LEAF -Q) [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) [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 [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 [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) [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) [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) [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)]
Eligibility criteria
Inclusion criteria
- Age range: from 18 years of age and up
- Currently active and NCAA-eligible (including academic standing) member of any Case Western Reserve University (CWRU) Athletic Team
- Signed Informed Consent
Exclusion criteria
- Under 18 years of age
- Pregnant women or women who are nursing
- Unwilling to provide anthropometrics, questionnaires or other collection needs
- History of a diagnosed disordered eating
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Case Western Reserve University — Cleveland
Publications
- Thomas DT, Erdman KA, Burke LM. Position of the Academy of Nutrition and Dietetics, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and Athletic Performance. J Acad Nutr Diet. 2016 Mar;116(3):501-528. doi: 10.1016/j.jand.2015.12.006. PMID 26920240
- Mountjoy M, Sundgot-Borgen J, Burke L, Carter S, Constantini N, Lebrun C, Meyer N, Sherman R, Steffen K, Budgett R, Ljungqvist A. The IOC consensus statement: beyond the Female Athlete Triad--Relative Energy Deficiency in Sport (RED-S). Br J Sports Med. 2014 Apr;48(7):491-7. doi: 10.1136/bjsports-2014-093502. PMID 24620037
Identifiers
NCT: NCT07136038 · STUDY20250865