Relative Energy Deficiency in Sport Multicenter Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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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);
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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);
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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);
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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);
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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.)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Global screening of high-performance athletes for REDS This arm collects data with an online survey to assess prevalence and signs and symptoms of REDS in elite female and male elite and recreational athletes and para-athletes over the age of 15 years across the world. |
|
| No Intervention: Basic screening of Canadian high-performance athletes for REDS In this study arm, varsity level to elite Canadian athletes and para-athletes will complete a baseline blood sample and potentially (where abnormalities are present) a follow-up 6 months later. |
|
| No Intervention: Advanced screening of Canadian high-performance athletes for REDS In this study arm, varsity level to elite Canadian athletes and para-athletes will complete a baseline test for bone density (DXA scans), resting metabolic rate and exercise testing. Potentially (where abnormalities are present) a follow-up 6 months later. |
|
| Experimental: Treatment of Canadian athletes with REDS: a holistic intervention arm In this arm, varsity level to elite Canadian athletes and para-athletes with REDS will participate in a nutritional intervention aiming to improve energy availability and thus, REDS status. |
Behavioral: Treatment 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.
|
Outcome Measures
Primary Outcome Measures
- REDS clinical assessment tool and REDS risk score [Baseline and possibly change after 6 months for a subset of athletes]
a combination of validated and semi-validated questionnaires
- Menstrual function in females [Baseline and possibly change after 6 months for a subset of athletes]
via 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 concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Estrogen concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Testosterone concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Luteinizing hormone concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Follicle-stimulating hormone concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Sex-hormone binding globulin concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Hemoglobin concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Ferritin concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Serum iron concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Total iron binding capacity [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Iron saturation [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Total cholesterol concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- LDL cholesterol concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- HDL cholesterol concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Triglycerides concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Bone mineral density [Baseline]
Dual energy x ray scan of lumbar spine and femoral neck bone density
- Resting metabolic rate [Baseline and possibly change after 6 months for a subset of athletes]
Assessment done with a metabolic cart by collecting respiratory gases
- Aerobic capacity [Baseline and possibly change after 6 months for a subset of athletes]
maximal oxygen uptake test
- Strength [Baseline and possibly change after 6 months for a subset of athletes]
Maximal strength tests
- Insulin like growth factor 1 concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Resting heart rate [Baseline and possibly change after 6 months for a subset of athletes]
Heart rate monitor (Polar electro)
- Blood pressure (systolic and diastolic) [Baseline and possibly change after 6 months for a subset of athletes]
Blood pressure monitor
- Bone stress injury history [Baseline and possibly change after 6 months for a subset of athletes]
online questionnaire on type and number of injuries
Secondary Outcome Measures
- Body composition [Baseline and possibly change after 6 months for a subset of athletes]
Via DXA or skinfold calipers
- Complete blood count [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Insulin concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Glucose concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Cortisol concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- Prolactin concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- 25(OH)D concentrations [Baseline and possibly change after 6 months for a subset of athletes]
Venous blood samples
- illness history [Baseline and possibly change after 6 months for a subset of athletes]
online questionnaire on frequency of illness in the past 24 months
- Soft-tissue injury history [Baseline and possibly change after 6 months for a subset of athletes]
online questionnaire on the type and number of injuries in the past 24 months
- Sleep hygiene [Baseline and possibly change after 6 months for a subset of athletes]
Athlete Sleep Screening Questionnaire (higher scores reflect sleep impairments)
- Mental health [Baseline and possibly change after 6 months for a subset of athletes]
Depression, anxiety and stress scale 21 (higher scores reflect increased mental challenges)
- Male athlete health [Baseline and possibly change after 6 months for a subset of athletes]
Low Energy Availability in Males Questionnaire (scoring is under development but higher scores reflect higher risk of REDS)
- Gut health [Baseline and possibly change after 6 months for a subset of athletes]
Sections from the LEAF-Q (higher scores reflect higher risk of REDS)
- Cardiac health [Baseline and possibly change after 6 months for a subset of athletes]
Questions from the Pre-Participation Examination questionnaire (higher scores reflect higher risk of cardiac symptoms)
- Mood state [Baseline and possibly change after 6 months for a subset of athletes]
Brunel Mood Scales (higher scores reflect higher mood disturbance)
- Eating disorder assessment [Baseline and possibly change after 6 months for a subset of athletes]
Eating Disorder Examination 3 (higher scores reflect higher risk of eating disorders)
- History of weight change [Baseline and possibly change after 6 months for a subset of athletes]
online questionnaire
- History of anemia [Baseline and possibly change after 6 months for a subset of athletes]
online questionnaire
- REDS treatment arm [Individualised but likely 3-6 months]
holistic nutrition based treatment of REDS symptoms including increasing energy availability via nutrition counselling
Eligibility Criteria
Criteria
Inclusion Criteria:
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International or Canadian elite (National Sport Organization identified) and (Provincial Sport Organization / University varsity identified) Next Generation, or recreational athlete or para-athlete
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Female or male athlete or para-athlete currently and actively training for and racing in an Olympic sports event
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Age >15 years
Exclusion Criteria:
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Under 15 years old
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Pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Victoria | Victoria | British Columbia | Canada | V8W 2Y2 |
Sponsors and Collaborators
- Trent Stellingwerff
- Mitacs
- University of British Columbia
Investigators
- Principal Investigator: Trent Stellingwerff, Ph.D., Canadian Sport Institute Pacific, University of Victoria, University of British Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RED-S multicenter 2020-22