Preventing Athlete Under-fueling Through Nutrition.

NCT07136038 | Recruiting

• 1 other identifier: STUDY20250865
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Athlete; Relative Energy Deficiency in Sport; Low Energy Availability

Keywords

collegiate; sport; lean body mass; fat mass

Outcome Measures

Primary Outcomes (1)

• Grip Strength

  Grip force in kilograms determined by a handgrip dynamometer, conducted on both arms, according to standard practice procedures.

  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 Outcomes (7)

• Low Energy Availability in Females Questionnaire (LEAF -Q)

  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)

  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

  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

  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)

  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)

Study Arms (1)

Athletes

EXPERIMENTAL

Behavioral: Low Energy Availability Screening and Nutrition Support

Interventions

Low Energy Availability Screening and Nutrition Support BEHAVIORAL

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.

Athletes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Pennington Biomedical Research Center: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Relative Energy Deficiency in Sport

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Kristyen Tomcik, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristyen Tomcik, PhD

CONTACT

216.368.0708; kat20@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group, open label nutrition intervention

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 22, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)