Relative Energy Deficiency in Sport Multicenter Study

Not Applicable

• Conditions: Nutrition Disorders; Athletic Injuries; Mental Health Wellness 1; Hormone Disturbance; Exercise-related Amenorrhea; Weight Change, Body; Bone Fracture; Health, Subjective; Eating Disorders; Sleep Hygiene
• Interventions: Behavioral: Treatment of REDS using a holistic treatment arm

• Registration Number: NCT04766203
• Lead Sponsor: Trent Stellingwerff

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.)

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-23
• Study Start: 2021-05-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-02
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment of Canadian athletes with REDS: a holistic intervention arm	Treatment of REDS using a holistic treatment 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.

Primary Outcome Measures

Name	Time	Method
Iron saturation	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
Total iron binding capacity	Baseline and possibly change after 6 months for a subset of athletes	Venous blood samples
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
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
Serum iron 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
Hemoglobin concentrations	Baseline and possibly change after 6 months for a subset of athletes	Venous blood samples
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
Ferritin 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
Triglycerides concentrations	Baseline and possibly change after 6 months for a subset of athletes	Venous blood samples
Strength	Baseline and possibly change after 6 months for a subset of athletes	Maximal strength tests
Testosterone 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)
Insulin like growth factor 1 concentrations	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
Bone mineral density	Baseline	Dual energy x ray scan of lumbar spine and femoral neck bone density
Blood pressure (systolic and diastolic)	Baseline and possibly change after 6 months for a subset of athletes	Blood pressure monitor
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
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

Name	Time	Method
Body composition	Baseline and possibly change after 6 months for a subset of athletes	Via DXA or skinfold calipers
Insulin 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
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)
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
Prolactin concentrations	Baseline and possibly change after 6 months for a subset of athletes	Venous blood samples
Complete blood count	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
25(OH)D concentrations	Baseline and possibly change after 6 months for a subset of athletes	Venous blood samples
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)
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)
Mood state	Baseline and possibly change after 6 months for a subset of athletes	Brunel Mood Scales (higher scores reflect higher mood disturbance)
REDS treatment arm	Individualised but likely 3-6 months	holistic nutrition based treatment of REDS symptoms including increasing energy availability via nutrition counselling
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
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)
History of anemia	Baseline and possibly change after 6 months for a subset of athletes	online questionnaire

Trial Locations

Locations (1)

University of Victoria; 🇨🇦 Victoria, British Columbia, Canada