Clinical trial NCT04766203: Relative Energy Deficiency in Sport Multicenter Study
Official title: Relative Energy Deficiency in Sport (RED-S) in International and Canadian High Performance Athletes: Prevalence, Health and Performance Implications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health, Subjective
Nutrition Disorders
Athletic Injuries
Hormone Disturbance
Exercise-related Amenorrhea
Eating Disorders
Sleep Hygiene
Cardiovascular Abnormalities
Bone Fracture
Bone Loss
Weight Change, Body
Mental Health Wellness 1
Lead sponsor: University of Victoria
Sponsor class: OTHER
Collaborators: name: Mitacs
name: University of British Columbia
First posted: 2021-02-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SCREENING

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.)

Eligibility criteria: 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

Primary outcomes:
measure: REDS clinical assessment tool and REDS risk score
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Menstrual function in females
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Triiodothyronine concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Estrogen concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Testosterone concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Luteinizing hormone concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Follicle-stimulating hormone concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Sex-hormone binding globulin concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Hemoglobin concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Ferritin concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Serum iron concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Total iron binding capacity
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Iron saturation
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Total cholesterol concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: LDL cholesterol concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: HDL cholesterol concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Triglycerides concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Bone mineral density
timeFrame: Baseline
measure: Resting metabolic rate
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Aerobic capacity
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Strength
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Insulin like growth factor 1 concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Resting heart rate
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Blood pressure (systolic and diastolic)
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Bone stress injury history
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
Secondary outcomes:
measure: Body composition
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Complete blood count
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Insulin concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Glucose concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Cortisol concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Prolactin concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: 25(OH)D concentrations
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: illness history
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Soft-tissue injury history
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Sleep hygiene
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Mental health
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Male athlete health
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Gut health
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Cardiac health
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Mood state
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: Eating disorder assessment
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: History of weight change
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: History of anemia
timeFrame: Baseline and possibly change after 6 months for a subset of athletes
measure: REDS treatment arm
timeFrame: Individualised but likely 3-6 months
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: University of Victoria
state: British Columbia
Study officials:
affiliation: Canadian Sport Institute Pacific, University of Victoria, University of British Columbia
name: Trent Stellingwerff, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: