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Relative Energy Deficiency in Sport Multicenter Study

Relative Energy Deficiency in Sport (RED-S) in International and Canadian High Performance Athletes: Prevalence, Health and Performance Implications

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04766203
Enrollment
2000
Registered
2021-02-23
Start date
2021-05-05
Completion date
2022-07-31
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athletic Injuries, Bone Fracture, Bone Loss, Cardiovascular Abnormalities, Eating Disorders, Exercise-related Amenorrhea, Health, Subjective, Hormone Disturbance, Mental Health Wellness 1, Nutrition Disorders, Sleep Hygiene, Weight Change, Body

Brief summary

Relative Energy Deficiency in Sport (RED-S) characterizes a range of negative health and performance outcomes that result from chronically low energy availability. RED-S concerns high performance junior and senior athletes across Canada and has a prevalence rate of 3-60%. Our ability to assess and diagnose RED-S remains poor. Accordingly, we aim to create the best parameters to diagnose and manage RED-S; along with information of the prevalence and severity across Canada and globally. These outcomes are expected to have a significant positive impact on the health and performance of Canadian athletes in preparation for the Olympic Games in 2022 and beyond.

Detailed description

Purpose: Our aim is to improve our understanding of the prevalence and symptoms of RED-S in international and Canadian athletes and para-athletes, along with developing screening tools and treatment protocols to manage RED-S in order to improve athlete health, availability and performance. Objectives: 1. Assess the prevalence of self-reported RED-S health outcomes in international and Canadian elite female and male athletes and para-athletes as well as recreational athletes (Study A); 2. Assess the prevalence and severity of measured standard/basic RED-S health outcomes including biomarkers and potential longitudinal (6-mo) tracking of outcomes across the Canadian Olympic and Paralympic Sport Institute Network (COPSI) (Study B); 3. Implement a more advanced assessment, using novel RED-S assessment parameters in a smaller cohort of key athletes, including potential longitudinal tracking over a 6-mo period (Study C); 4. Assess longitudinal changes and the treatment of RED-S symptoms across a 6-month follow-up period in a small cohort of elite Canadian athletes willing to partake in an 'holistic' RED-S treatment intervention arm (Study D); 5. Utilize the data created from Studies A,B,C,and D to develop and validate potentially novel RED-S assessment parameters in order to further validate the 'new' IOC RED-S clinical assessment tool (CAT) version 2 to aid in the diagnosis of RED-S. Justification: This study will be the first to systematically assess the prevalence and severity of outcomes of RED-S in a large group of international and Canadian athletes and para-athletes (A), and within the COPSI network (B,C), utilising physiological and performance tests and training metrics for a more holistic assessment of potential outcomes (B,C,). This study will also aim to strengthen the literature regarding to the time-course of changes in these outcomes (B,C,D) and the efficacy of a simple nutritional intervention arm on these changes (D). Finally, this multicentre project will be the largest to date in Canada and globally, and the first to produce data on the prevalence of RED-S within the COPSI network (across A,B,C,D). Research Design: This is an observational study including online survey and physiological testing with potential for follow-up in a subset of athletes. A separate study arm (study D) will be an intervention arm with follow-up. Statistical analysis: Analysis will be a combination of basic statistics such as t-tests and ANOVA's, as well as more advanced statistical modelling (e.g. stepwise regression modelling, with first identifying collinearity among independent variables via the implementation of variance inflation factors (VIFs)) as well as questionnaire-based statistics and potentially principal components analysis (PCA) will be implemented. Physiological data will be plotted against survey data to create links between RED-S symptoms among various athlete groups (female vs male, able bodied vs disabled, sports groups, age categories, etc.)

Interventions

BEHAVIORALTreatment of REDS using a holistic treatment arm

This arm aims to treat athletes with REDS symptoms by implementing a holistic, individualized nutrition intervention to improve energy availability and thus restore impaired body function due to REDS.

Sponsors

Mitacs
CollaboratorINDUSTRY
University of British Columbia
CollaboratorOTHER
Trent Stellingwerff
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

This study will be comprised of: 1) screening of athletes for symptoms of REDS; and 2) treating athletes diagnosed with REDS with a nutritional intervention

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* International or Canadian elite (National Sport Organization identified) and (Provincial Sport Organization / University varsity identified) Next Generation, or recreational athlete or para-athlete * Female or male athlete or para-athlete currently and actively training for and racing in an Olympic sports event * Age \>15 years

Exclusion criteria

* Under 15 years old * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Bone stress injury historyBaseline and possibly change after 6 months for a subset of athletesonline questionnaire on type and number of injuries
Luteinizing hormone concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Follicle-stimulating hormone concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Sex-hormone binding globulin concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Hemoglobin concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Ferritin concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Serum iron concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Total iron binding capacityBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Iron saturationBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Total cholesterol concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
LDL cholesterol concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
HDL cholesterol concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Triglycerides concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Bone mineral densityBaselineDual energy x ray scan of lumbar spine and femoral neck bone density
Resting metabolic rateBaseline and possibly change after 6 months for a subset of athletesAssessment done with a metabolic cart by collecting respiratory gases
Aerobic capacityBaseline and possibly change after 6 months for a subset of athletesmaximal oxygen uptake test
StrengthBaseline and possibly change after 6 months for a subset of athletesMaximal strength tests
Insulin like growth factor 1 concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Resting heart rateBaseline and possibly change after 6 months for a subset of athletesHeart rate monitor (Polar electro)
Blood pressure (systolic and diastolic)Baseline and possibly change after 6 months for a subset of athletesBlood pressure monitor
REDS clinical assessment tool and REDS risk scoreBaseline and possibly change after 6 months for a subset of athletesa combination of validated and semi-validated questionnaires
Menstrual function in femalesBaseline and possibly change after 6 months for a subset of athletesvia Low Energy Availability in Females Questionnaire (higher scores reflect higher risk of RED-S) and use of urinary ovulation strips to measure LH surge
Triiodothyronine concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Estrogen concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Testosterone concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples

Secondary

MeasureTime frameDescription
Complete blood countBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Insulin concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Glucose concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Cortisol concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
Prolactin concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
25(OH)D concentrationsBaseline and possibly change after 6 months for a subset of athletesVenous blood samples
illness historyBaseline and possibly change after 6 months for a subset of athletesonline questionnaire on frequency of illness in the past 24 months
Soft-tissue injury historyBaseline and possibly change after 6 months for a subset of athletesonline questionnaire on the type and number of injuries in the past 24 months
Sleep hygieneBaseline and possibly change after 6 months for a subset of athletesAthlete Sleep Screening Questionnaire (higher scores reflect sleep impairments)
Mental healthBaseline and possibly change after 6 months for a subset of athletesDepression, anxiety and stress scale 21 (higher scores reflect increased mental challenges)
Male athlete healthBaseline and possibly change after 6 months for a subset of athletesLow Energy Availability in Males Questionnaire (scoring is under development but higher scores reflect higher risk of REDS)
Gut healthBaseline and possibly change after 6 months for a subset of athletesSections from the LEAF-Q (higher scores reflect higher risk of REDS)
Cardiac healthBaseline and possibly change after 6 months for a subset of athletesQuestions from the Pre-Participation Examination questionnaire (higher scores reflect higher risk of cardiac symptoms)
Mood stateBaseline and possibly change after 6 months for a subset of athletesBrunel Mood Scales (higher scores reflect higher mood disturbance)
Eating disorder assessmentBaseline and possibly change after 6 months for a subset of athletesEating Disorder Examination 3 (higher scores reflect higher risk of eating disorders)
History of weight changeBaseline and possibly change after 6 months for a subset of athletesonline questionnaire
History of anemiaBaseline and possibly change after 6 months for a subset of athletesonline questionnaire
REDS treatment armIndividualised but likely 3-6 monthsholistic nutrition based treatment of REDS symptoms including increasing energy availability via nutrition counselling
Body compositionBaseline and possibly change after 6 months for a subset of athletesVia DXA or skinfold calipers

Countries

Canada

Contacts

Primary ContactTrent Stellingwerff, Ph.D.
tstellingwerff@csipacific.ca250-208-6674
Backup ContactIda A Heikura, Ph.D.
iheikura@csipacific.ca778-587-8508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026