Nutrition Support for Underfueling

(PERFORM Trial)

Overseen By Kristyen Tomcik, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Under 18, Pregnant, Disordered eating, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the screening and support of Division III athletes for nutrition. Researchers will measure height, weight, and grip strength, and athletes will complete questionnaires. Dietitians trained in sports nutrition will provide advice to help athletes manage their energy intake. The trial focuses on active NCAA-eligible athletes at Case Western Reserve University. Athletes at CWRU who meet these criteria could benefit from optimized nutrition for better health and performance. As an unphased trial, this study offers a unique opportunity for personalized nutritional support to enhance performance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nutrition support and screening for athletes.

What prior data suggests that this nutrition support method is safe for athletes?

Research has shown that nutrition support and screening methods are safe and well-tolerated for athletes. Studies have found that tools for checking low energy availability (when the body lacks enough energy for all activities) are effective and safe. These tools include simple measurements like height and weight, along with questionnaires that identify energy gaps in athletes.

No reports of serious side effects from these methods exist. Sports nutrition dietitians use information from these tools to offer personalized advice. This approach aims to enhance health and performance without causing harm. Overall, the focus remains on ensuring athletes receive the right nutrients safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition Support for Underfueling trial because it aims to address low energy availability in athletes, a condition often managed by general dietary advice or calorie-tracking. Unlike standard approaches, this trial uses a targeted Low Energy Availability Screening combined with personalized nutrition support. This method is unique because it directly assesses athletes' energy needs and provides tailored nutritional guidance to optimize their energy intake, potentially improving performance and health outcomes more effectively than one-size-fits-all strategies.

What evidence suggests that this nutrition support is effective for improving athletes' health and performance?

This trial will focus on providing Low Energy Availability Screening and Nutrition Support to athletes. Studies have shown that insufficient energy intake from food can lead to health and performance issues, often referred to as the athlete triad or RED-S (Relative Energy Deficiency in Sport). Research indicates that proper nutrition ensures athletes consume enough to meet their exercise demands. Nutritional support has been linked to improved health and performance. Previous studies found that educating athletes about nutrition can reduce the risk of inadequate energy intake. Early findings suggest that regular nutrition check-ups and personalized advice effectively support athletes' energy needs. ^{6 7 8 9 10}

Who Is on the Research Team?

Kristyen Tomcik, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for Division III athletes who may be under-fueling, which can affect their health and performance. Participants will undergo nutrition screenings and receive advice from sports dietitians.

Inclusion Criteria

I am 18 years old or older.

Currently active and NCAA-eligible (including academic standing) member of any Case Western Reserve University (CWRU) Athletic Team

Signed Informed Consent

Exclusion Criteria

I am unwilling to share my body measurements or answer questionnaires.

Pregnant women or women who are nursing

I am younger than 18.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-season Assessment

Baseline data collection including anthropometrics, grip strength, body composition, and questionnaires

1 week

1 visit (in-person)

Mid-season Assessment

Mid-season data collection to monitor changes in athlete health and performance metrics

1 week

1 visit (in-person)

Post-season Assessment

End of study data collection to evaluate the impact of nutrition support on athlete health and performance

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any long-term effects of the nutrition intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low Energy Availability Screening and Nutrition Support

Trial Overview The study tests a program of regular nutrition screening and personalized dietary support to prevent under-fueling in athletes. Measurements are taken before, during, and after the season to track changes.

How Is the Trial Designed?

Group I: Athletes Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7146210/

Low Energy Availability in Athletes 2020 Low energy availability (EA) underpins the female and male athlete triad and relative energy deficiency in sport (RED-S).

2. sciencedirect.com sciencedirect.com/science/article/pii/S1440244024001075

The relationship between nutrition knowledge and low ... This was a pilot study that examined the relationship between nutrition knowledge and risk for low energy availability (LEA) in NCAA athletes.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0314506

Nutrition educational interventions for athletes related to low ... Low energy availability surrogates correlate with health and performance consequences of Relative Energy Deficiency in Sport. Br J Sports Med. 2019;53: 628 ...

4. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-021-00396-7

Review: questionnaires as measures for low energy ... Low energy availability surrogates correlate with health and performance consequences of relative energy deficiency in sport. Br J Sports ...

5. bmjopensem.bmj.com bmjopensem.bmj.com/content/10/4/e002193

Energy availability and its association with health-related ... Background Low energy availability (LEA) occurs when athletes' energy intake fails to match the energy expended during exercise, resulting in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12377126/

validation of the low energy availability in female questionnaire The LEAFQ-ITA is a valid instrument for identifying Italian physically active women with physiological symptoms possibly related to LEA or REDs.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667268524001281

Assessment of relative energy deficiency in sport and ... This study investigated the relationship between REDs screening, BIA assessment of malnutrition and ovulatory status in female endurance runners.

8. nationaleatingdisorders.org nationaleatingdisorders.org/relative-energy-deficiency-in-sport-red-s/

Relative Energy Deficiency in Sport (REDs) Low energy availability is the primary component of REDs whereby there is a mismatch between an athlete's nutritional/energy intake and the energy expended ...

9. sportsmedicine-open.springeropen.com sportsmedicine-open.springeropen.com/articles/10.1186/s40798-020-00275-6

Reasons for and Consequences of Low Energy Availability in ... Low energy availability (LEA) represents a state in which the body does not have enough energy left to support all physiological functions ...

10. stillmed.olympics.com stillmed.olympics.com/media/Documents/Athletes/Medical-Scientific/Consensus-Statements/REDs/IOC-REDs-CAT-Version-2.pdf

IOC REDs CAT2 The IOC REDs CAT2 is a clinical assessment tool for the evaluation of athletes/active individuals suspected of having problematic low energy availability ...