An interventional study of Treatment of REDS using a holistic treatment arm in Health, Subjective, Nutrition Disorders and Athletic Injuries, sponsored by Trent Stellingwerff. Status unknown at 1 site in Canada. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by Trent Stellingwerff · Not applicable, Interventional, and Screening
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.
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:
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.)
59 studies on the registry are indexed under Cardiovascular Abnormalities; 14 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 60 across 33 interventional studies indexed under Cardiovascular Abnormalities.
Browse Cardiovascular Abnormalities studies →This is the only study on the registry with Trent Stellingwerff as lead sponsor.
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Exclusion Criteria:
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.
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.
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.
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.
REDS clinical assessment tool and REDS risk score
a combination of validated and semi-validated questionnaires
Time frame: Baseline and possibly change after 6 months for a subset of athletes
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
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Triiodothyronine concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Estrogen concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Testosterone concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Luteinizing hormone concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Follicle-stimulating hormone concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Sex-hormone binding globulin concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Hemoglobin concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Ferritin concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Serum iron concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Total iron binding capacity
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Iron saturation
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Total cholesterol concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
LDL cholesterol concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
HDL cholesterol concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Triglycerides concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Bone mineral density
Dual energy x ray scan of lumbar spine and femoral neck bone density
Time frame: Baseline
Resting metabolic rate
Assessment done with a metabolic cart by collecting respiratory gases
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Aerobic capacity
maximal oxygen uptake test
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Strength
Maximal strength tests
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Insulin like growth factor 1 concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Resting heart rate
Heart rate monitor (Polar electro)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Blood pressure (systolic and diastolic)
Blood pressure monitor
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Bone stress injury history
online questionnaire on type and number of injuries
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Body composition
Via DXA or skinfold calipers
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Complete blood count
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Insulin concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Glucose concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Cortisol concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Prolactin concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
25(OH)D concentrations
Venous blood samples
Time frame: Baseline and possibly change after 6 months for a subset of athletes
illness history
online questionnaire on frequency of illness in the past 24 months
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Soft-tissue injury history
online questionnaire on the type and number of injuries in the past 24 months
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Sleep hygiene
Athlete Sleep Screening Questionnaire (higher scores reflect sleep impairments)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Mental health
Depression, anxiety and stress scale 21 (higher scores reflect increased mental challenges)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Male athlete health
Low Energy Availability in Males Questionnaire (scoring is under development but higher scores reflect higher risk of REDS)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Gut health
Sections from the LEAF-Q (higher scores reflect higher risk of REDS)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Cardiac health
Questions from the Pre-Participation Examination questionnaire (higher scores reflect higher risk of cardiac symptoms)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Mood state
Brunel Mood Scales (higher scores reflect higher mood disturbance)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Eating disorder assessment
Eating Disorder Examination 3 (higher scores reflect higher risk of eating disorders)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
History of weight change
online questionnaire
Time frame: Baseline and possibly change after 6 months for a subset of athletes
History of anemia
online questionnaire
Time frame: Baseline and possibly change after 6 months for a subset of athletes
REDS treatment arm
holistic nutrition based treatment of REDS symptoms including increasing energy availability via nutrition counselling
Time frame: Individualised but likely 3-6 months
Plan to share: No — No data will be shared with researchers outside of the study team.
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