Relative Energy Deficiency in Sport Multicenter Study

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trent Stellingwerff, Ph.D.; Phone Number: 250-208-6674; Email: tstellingwerff@csipacific.ca
• Study Contact Backup: Name: Ida A Heikura, Ph.D.; Phone Number: 778-587-8508; Email: iheikura@csipacific.ca

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8W 2Y2
      • Recruiting
      • University of Victoria
      • Contact: Ida A Heikura, Ph.D.; Phone Number: 778-587-8508; Email: iheikura@csipacific.ca
      • Contact: Trent Stellingwerff, Ph.D.; Phone Number: 250-220-6674; Email: tstellingwerff@csipacific.ca
      • Principal Investigator: Trent Stellingwerff, Ph.D.
      • Sub-Investigator: Ida A Heikura, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Triiodothyronine concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Estrogen concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Testosterone concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Luteinizing hormone concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Follicle-stimulating hormone concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Sex-hormone binding globulin concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Hemoglobin concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Ferritin concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Serum iron concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Total iron binding capacity	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Iron saturation	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Total cholesterol concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
LDL cholesterol concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
HDL cholesterol concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Triglycerides concentrations	Venous blood samples	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	Baseline
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
Aerobic capacity	maximal oxygen uptake test	Baseline and possibly change after 6 months for a subset of athletes
Strength	Maximal strength tests	Baseline and possibly change after 6 months for a subset of athletes
Insulin like growth factor 1 concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Resting heart rate	Heart rate monitor (Polar electro)	Baseline and possibly change after 6 months for a subset of athletes
Blood pressure (systolic and diastolic)	Blood pressure monitor	Baseline and possibly change after 6 months for a subset of athletes
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Via DXA or skinfold calipers	Baseline and possibly change after 6 months for a subset of athletes
Complete blood count	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Insulin concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Glucose concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Cortisol concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
Prolactin concentrations	Venous blood samples	Baseline and possibly change after 6 months for a subset of athletes
25(OH)D concentrations	Venous blood samples	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	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	Baseline and possibly change after 6 months for a subset of athletes
Sleep hygiene	Athlete Sleep Screening Questionnaire (higher scores reflect sleep impairments)	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)	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)	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)	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)	Baseline and possibly change after 6 months for a subset of athletes
Mood state	Brunel Mood Scales (higher scores reflect higher mood disturbance)	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)	Baseline and possibly change after 6 months for a subset of athletes
History of weight change	online questionnaire	Baseline and possibly change after 6 months for a subset of athletes
History of anemia	online questionnaire	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	Individualised but likely 3-6 months

Collaborators and Investigators

• Sponsor: Trent Stellingwerff
• Collaborators: University of British Columbia; Mitacs
• Investigators: Principal Investigator: Trent Stellingwerff, Ph.D., Canadian Sport Institute Pacific, University of Victoria, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Wounds and Injuries; Congenital Abnormalities; Body Weight; Menstruation Disturbances; Disease; Feeding and Eating Disorders; Fractures, Bone; Amenorrhea; Body Weight Changes; Nutrition Disorders; Endocrine System Diseases; Cardiovascular Abnormalities; Athletic Injuries; Relative Energy Deficiency in Sport
• Other Study ID Numbers: RED-S multicenter 2020-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No data will be shared with researchers outside of the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No