Relative Energy Deficiency in Sport Multicenter Study

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766203
• Other study ID #: RED-S multicenter 2020-22
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: June 2021
• Source: University of Victoria
• Contact: Trent Stellingwerff, Ph.D.
• Phone: 250-208-6674
• Email: tstellingwerff[@]csipacific.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Amenorrhea
• Athletic Injuries
• Body Weight Changes
• Bone Fracture
• Bone Loss
• Cardiovascular Abnormalities
• Disease
• Eating Disorders
• Endocrine System Diseases
• Exercise-related Amenorrhea
• Feeding and Eating Disorders
• Fractures, Bone
• Health, Subjective
• Hormone Disturbance
• Mental Health Wellness 1
• Nutrition Disorders
• Sleep Hygiene
• Weight Change, Body

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Victoria	Victoria	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Trent Stellingwerff	Mitacs, University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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