Eating Disorders Clinical Trial
Official title:
Relative Energy Deficiency in Sport (RED-S) in International and Canadian High Performance Athletes: Prevalence, Health and Performance Implications
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Victoria | Victoria | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Trent Stellingwerff | Mitacs, University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | REDS clinical assessment tool and REDS risk score | a combination of validated and semi-validated questionnaires | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Menstrual function in females | 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 | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Triiodothyronine concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Estrogen concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Testosterone concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Luteinizing hormone concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Follicle-stimulating hormone concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Sex-hormone binding globulin concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Hemoglobin concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Ferritin concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Serum iron concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Total iron binding capacity | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Iron saturation | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Total cholesterol concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | LDL cholesterol concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | HDL cholesterol concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Triglycerides concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Bone mineral density | Dual energy x ray scan of lumbar spine and femoral neck bone density | Baseline | |
Primary | Resting metabolic rate | Assessment done with a metabolic cart by collecting respiratory gases | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Aerobic capacity | maximal oxygen uptake test | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Strength | Maximal strength tests | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Insulin like growth factor 1 concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Resting heart rate | Heart rate monitor (Polar electro) | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Blood pressure (systolic and diastolic) | Blood pressure monitor | Baseline and possibly change after 6 months for a subset of athletes | |
Primary | Bone stress injury history | online questionnaire on type and number of injuries | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Body composition | Via DXA or skinfold calipers | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Complete blood count | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Insulin concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Glucose concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Cortisol concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Prolactin concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | 25(OH)D concentrations | Venous blood samples | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | illness history | online questionnaire on frequency of illness in the past 24 months | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Soft-tissue injury history | online questionnaire on the type and number of injuries in the past 24 months | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Sleep hygiene | Athlete Sleep Screening Questionnaire (higher scores reflect sleep impairments) | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Mental health | Depression, anxiety and stress scale 21 (higher scores reflect increased mental challenges) | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Male athlete health | Low Energy Availability in Males Questionnaire (scoring is under development but higher scores reflect higher risk of REDS) | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Gut health | Sections from the LEAF-Q (higher scores reflect higher risk of REDS) | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Cardiac health | Questions from the Pre-Participation Examination questionnaire (higher scores reflect higher risk of cardiac symptoms) | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Mood state | Brunel Mood Scales (higher scores reflect higher mood disturbance) | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | Eating disorder assessment | Eating Disorder Examination 3 (higher scores reflect higher risk of eating disorders) | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | History of weight change | online questionnaire | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | History of anemia | online questionnaire | Baseline and possibly change after 6 months for a subset of athletes | |
Secondary | REDS treatment arm | holistic nutrition based treatment of REDS symptoms including increasing energy availability via nutrition counselling | Individualised but likely 3-6 months |
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