Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000954325p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
26/06/2026
Date registered
Help: Date registered
3/08/2026
Date last updated
Help: Date last updated
3/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing different methods used to identify Relative Energy Deficiency in Sport (REDs) in youth and adult athletes and whether they classify athletes similarly
Scientific title
Evaluation of Diagnostic Tools for the Identification of Relative Energy Deficiency in Sport (REDs) in youth and adult Athletes: Differences in REDs Detection Rates
Additional trial identifiers [1] 317717 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Relative Energy Deficiency in Sport (REDs) 342601 0
Condition category
Condition code
Diet and Nutrition 338747 338747 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
This observational study will evaluate the performance of existing and emerging screening and diagnostic tools used to identify Relative Energy Deficiency in Sport (REDs). Participants will complete a range of assessments on a single occasion, allowing comparison of currently used diagnostic approaches with newer proposed tools.
- Risk of and presence of Relative Energy Deficiency in Sport (REDs) among athletes.
- Participants will be observed and assessed at a single time point. No follow-up assessments will be conducted.
Questionnaires: 4-day food diary, Low energy availability in females/males questionnaire (LEAF–Q or LEAM-Q) (currently used in the IOC CAT2), Eating Disorder examination questionnaire (EDE-Q) (CAT2), Androgen Deficiency in the Aging Male (ADAM-Q) (emerging), Pittsburgh Sleep Quality Index (PSQI) (emerging), Medical history (CAT2), Menstrual phase (females) (CAT2), Modified Visual Analog Scale Gut symptoms tool (emerging). (45-60 mins)
Anthropometry - Height, weight, fat free mass, fat mass, skeletal muscle mass, total body water (MBIA) (10 mins).
Resting metabolic rate (60 mins).
Venous blood sampling - 1 x Heparin, EDTA & silica clot – 18ml total. Testing - testosterone (CAT2), oestrogen (emerging), IGF-1 (emerging), cortisol (emerging), T3/T4 (CAT2), P1NP (emerging), CTX (emerging), phosphatase (emerging), CRP (emerging), hepcidin (emerging), LH/FSH (emerging), cytokines (emerging), REDD1 (emerging), plasma osmolality, FBC, plasma SCFA (emerging), IFAB (emerging). Capillary blood sample for glucose (emerging). (10 mins)
Full body dexa scan - body composition (emerging) (20 mins)
Performance and strength testing - VO2 max, Sprint testing 10m & 5m return, Dual tasking test (cognitive & performance), Counter movement jump, hand grip strength, full body squat pull, single leg hop (~60 mins). (all emerging)
Advanced imaging - HRpQCT (radius & tibia) assess bone density, pQCT (quadriceps) assess muscle density (~30 mins) (all emerging)
Study coordinator will be administering all tests, total duration 5-6 hours, expected all tests to occur on 1 day face to face.

The intention is for the results to be used as guidelines for by Sports Dietitians and Sports Physicians to be able to diagnose REDs more easily. The study is not diagnosing participants with REDs. Participants who appear to be at risk will be directed to their medical professional for further diagnosis and treatment.

All tools are pre-existing that are being investigated for a new application.
Intervention code [1] 334899 0
Not applicable
Description of the comparator or control
Comprehensive clinical assessment undertaken by clinicians experienced in REDs to determine an athlete's level of risk for Relative Energy Deficiency in Sport (REDs). The assessment incorporates relevant clinical, dietary, physiological, and performance information and serves as the reference assessment against which screening and assessment tools are compared.
Control group
Active

Outcomes
Primary outcome [1] 345954 0
Accuracy of REDs classification by existing and emerging diagnostic tools.
Timepoint [1] 345954 0
Single assessment conducted on one occasion during the study visit (with food diary and questionnaires completed in the 3–5 days prior to testing).
Primary outcome [2] 346136 0
Accuracy of REDs risk identification by existing and emerging diagnostic tools.
Timepoint [2] 346136 0
Single assessment conducted on one occasion during the study visit (with food diary and questionnaires completed in the 3–5 days prior to testing).
Secondary outcome [1] 463915 0
nil
Timepoint [1] 463915 0
nil

Eligibility
Key inclusion criteria
Male and female athletes aged 15 years or older who participate in regular sport training and/or competition and are willing and able to complete all study assessments, including questionnaires, dietary assessment, blood sampling, imaging, metabolic testing, and exercise/performance testing.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded if they are pregnant or breastfeeding; have an injury or medical condition that limits exercise participation; have a chronic endocrine, metabolic, or bone disorder; have an acute illness or infection; are taking medications known to affect hormonal, metabolic, or bone health; do not meet exercise testing safety requirements; or are unable or unwilling to complete the required questionnaires, dietary records, and testing procedures.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322257 0
University
Name [1] 322257 0
BASE Facility, Department of Nutrition, Dietetics and Food, Monash University
Country [1] 322257 0
Australia
Primary sponsor type
University
Name
BASE Facility, Department of Nutrition, Dietetics and Food, Monash University
Address
Country
Australia
Secondary sponsor category [1] 325501 0
None
Name [1] 325501 0
Address [1] 325501 0
Country [1] 325501 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320779 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 320779 0
Ethics committee country [1] 320779 0
Australia
Date submitted for ethics approval [1] 320779 0
23/06/2026
Approval date [1] 320779 0
Ethics approval number [1] 320779 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151594 0
Prof Ricardo Costa
Address 151594 0
BASE Facility, 264 Ferntree Gully Road, Notting Hill, VIC 3168
Country 151594 0
Australia
Phone 151594 0
+61 3 9905 6861
Fax 151594 0
Email 151594 0
[email protected]
Contact person for public queries
Name 151595 0
Angela Taylor
Address 151595 0
BASE Facility, 264 Ferntree Gully Road, Notting Hill, VIC 3168
Country 151595 0
Australia
Phone 151595 0
+61 3 9902 4270
Fax 151595 0
Email 151595 0
[email protected]
Contact person for scientific queries
Name 151596 0
Ricardo Costa
Address 151596 0
BASE Facility, 264 Ferntree Gully Road, Notting Hill, VIC 3168
Country 151596 0
Australia
Phone 151596 0
+61 3 9905 6861
Fax 151596 0
Email 151596 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.