AthletePERFORMNCT07136038
Preventing Athlete Under-fueling Through Nutrition.
A study testing Low Energy Availability Screening and Nutrition Support in people with Athlete and Relative Energy Deficiency in Sport, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Athlete, Relative Energy Deficiency in Sport, Low Energy Availability
- What is being tested?
- Low Energy Availability Screening and Nutrition Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Kristyen Tomcik, PhD, 216-368-0708, kristyen.tomcik@case.edu
About this study
Official title: Prevention and Education for RED-S Through Fueling Outcomes and Research in Metabolic Health
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.
Read the 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.
- Being tested
- Low Energy Availability Screening and Nutrition Support
- Keywords
- collegiate, sport, lean body mass, fat mass
- Medical subject headings
- Relative Energy Deficiency in Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Energy Availability Screening and Nutrition SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Athletes | Experimental | Not described Receives: Behavioral: Low Energy Availability Screening and Nutrition Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Grip force in kilograms determined by a handgrip dynamometer, conducted on both arms, according to standard practice procedures.
Measured: 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)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start19 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AthleteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, open label nutrition intervention
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Kristyen Tomcik, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136038
- Sponsor's protocol ID
- STUDY20250865
- Acronym
- PERFORM
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request, with appropriate data sharing agreements in place, and according to institutional policy.
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.
PubMed 26920240Mountjoy 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.
PubMed 24620037
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Education for RED-S Through Fueling Outcomes and Research in Metabolic Health
- ClinicalTrials.gov ID
- NCT07136038
- Acronym / sponsor ID
- PERFORM / STUDY20250865
- Keywords
- collegiate, sport, lean body mass, fat mass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, open label nutrition intervention
| Arm | Type | Receives |
|---|---|---|
| Athletes | Experimental | Behavioral: Low Energy Availability Screening and Nutrition Support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Energy Availability Screening and Nutrition SupportAthletes will receive screening for low energy availability, strength and body composition assessments and receive nutrition support from a sports dietitian over the competitive season. | Behavioural | Athletes |
Primary outcome
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)
Grip force in kilograms determined by a handgrip dynamometer, conducted on both arms, according to standard practice procedures.
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 26920240Thomas 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.
- Background: PubMed 24620037Mountjoy 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.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request, with appropriate data sharing agreements in place, and according to institutional policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristyen Tomcik, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Energy Availability Screening and Nutrition Support in people with Athlete and Relative Energy Deficiency in Sport, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristyen Tomcik, PhD (216.368.0708, kat20@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07136038, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.