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Relative Energy Deficiency in Sport Multicenter Study

Primary Purpose

Health, Subjective, Nutrition Disorders, Athletic Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Treatment of REDS using a holistic treatment arm
Sponsored by
Trent Stellingwerff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Health, Subjective

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of VictoriaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

No Intervention

Experimental

Arm Label

Global screening of high-performance athletes for REDS

Basic screening of Canadian high-performance athletes for REDS

Advanced screening of Canadian high-performance athletes for REDS

Treatment of Canadian athletes with REDS: a holistic intervention arm

Arm Description

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.

Outcomes

Primary Outcome Measures

REDS clinical assessment tool and REDS risk score
a combination of validated and semi-validated questionnaires
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
Triiodothyronine concentrations
Venous blood samples
Estrogen concentrations
Venous blood samples
Testosterone concentrations
Venous blood samples
Luteinizing hormone concentrations
Venous blood samples
Follicle-stimulating hormone concentrations
Venous blood samples
Sex-hormone binding globulin concentrations
Venous blood samples
Hemoglobin concentrations
Venous blood samples
Ferritin concentrations
Venous blood samples
Serum iron concentrations
Venous blood samples
Total iron binding capacity
Venous blood samples
Iron saturation
Venous blood samples
Total cholesterol concentrations
Venous blood samples
LDL cholesterol concentrations
Venous blood samples
HDL cholesterol concentrations
Venous blood samples
Triglycerides concentrations
Venous blood samples
Bone mineral density
Dual energy x ray scan of lumbar spine and femoral neck bone density
Resting metabolic rate
Assessment done with a metabolic cart by collecting respiratory gases
Aerobic capacity
maximal oxygen uptake test
Strength
Maximal strength tests
Insulin like growth factor 1 concentrations
Venous blood samples
Resting heart rate
Heart rate monitor (Polar electro)
Blood pressure (systolic and diastolic)
Blood pressure monitor
Bone stress injury history
online questionnaire on type and number of injuries

Secondary Outcome Measures

Body composition
Via DXA or skinfold calipers
Complete blood count
Venous blood samples
Insulin concentrations
Venous blood samples
Glucose concentrations
Venous blood samples
Cortisol concentrations
Venous blood samples
Prolactin concentrations
Venous blood samples
25(OH)D concentrations
Venous blood samples
illness history
online questionnaire on frequency of illness in the past 24 months
Soft-tissue injury history
online questionnaire on the type and number of injuries in the past 24 months
Sleep hygiene
Athlete Sleep Screening Questionnaire (higher scores reflect sleep impairments)
Mental health
Depression, anxiety and stress scale 21 (higher scores reflect increased mental challenges)
Male athlete health
Low Energy Availability in Males Questionnaire (scoring is under development but higher scores reflect higher risk of REDS)
Gut health
Sections from the LEAF-Q (higher scores reflect higher risk of REDS)
Cardiac health
Questions from the Pre-Participation Examination questionnaire (higher scores reflect higher risk of cardiac symptoms)
Mood state
Brunel Mood Scales (higher scores reflect higher mood disturbance)
Eating disorder assessment
Eating Disorder Examination 3 (higher scores reflect higher risk of eating disorders)
History of weight change
online questionnaire
History of anemia
online questionnaire
REDS treatment arm
holistic nutrition based treatment of REDS symptoms including increasing energy availability via nutrition counselling

Full Information

First Posted
February 16, 2021
Last Updated
June 1, 2021
Sponsor
Trent Stellingwerff
Collaborators
Mitacs, University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04766203
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Trent Stellingwerff
Collaborators
Mitacs, University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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); 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); 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); 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); 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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Global screening of high-performance athletes for REDS
Arm Type
No Intervention
Arm Description
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.
Arm Title
Basic screening of Canadian high-performance athletes for REDS
Arm Type
No Intervention
Arm Description
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.
Arm Title
Advanced screening of Canadian high-performance athletes for REDS
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treatment of Canadian athletes with REDS: a holistic intervention arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment of REDS using a holistic treatment arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
REDS clinical assessment tool and REDS risk score
Description
a combination of validated and semi-validated questionnaires
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Menstrual function in females
Description
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
Title
Triiodothyronine concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Estrogen concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Testosterone concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Luteinizing hormone concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Follicle-stimulating hormone concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Sex-hormone binding globulin concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Hemoglobin concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Ferritin concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Serum iron concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Total iron binding capacity
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Iron saturation
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Total cholesterol concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
LDL cholesterol concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
HDL cholesterol concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Triglycerides concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Bone mineral density
Description
Dual energy x ray scan of lumbar spine and femoral neck bone density
Time Frame
Baseline
Title
Resting metabolic rate
Description
Assessment done with a metabolic cart by collecting respiratory gases
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Aerobic capacity
Description
maximal oxygen uptake test
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Strength
Description
Maximal strength tests
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Insulin like growth factor 1 concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Resting heart rate
Description
Heart rate monitor (Polar electro)
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Blood pressure (systolic and diastolic)
Description
Blood pressure monitor
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Bone stress injury history
Description
online questionnaire on type and number of injuries
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Secondary Outcome Measure Information:
Title
Body composition
Description
Via DXA or skinfold calipers
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Complete blood count
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Insulin concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Glucose concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Cortisol concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Prolactin concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
25(OH)D concentrations
Description
Venous blood samples
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
illness history
Description
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
Title
Soft-tissue injury history
Description
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
Title
Sleep hygiene
Description
Athlete Sleep Screening Questionnaire (higher scores reflect sleep impairments)
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Mental health
Description
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
Title
Male athlete health
Description
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
Title
Gut health
Description
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
Title
Cardiac health
Description
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
Title
Mood state
Description
Brunel Mood Scales (higher scores reflect higher mood disturbance)
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
Eating disorder assessment
Description
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
Title
History of weight change
Description
online questionnaire
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
History of anemia
Description
online questionnaire
Time Frame
Baseline and possibly change after 6 months for a subset of athletes
Title
REDS treatment arm
Description
holistic nutrition based treatment of REDS symptoms including increasing energy availability via nutrition counselling
Time Frame
Individualised but likely 3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trent Stellingwerff, Ph.D.
Phone
250-208-6674
Email
tstellingwerff@csipacific.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ida A Heikura, Ph.D.
Phone
778-587-8508
Email
iheikura@csipacific.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trent Stellingwerff, Ph.D.
Organizational Affiliation
Canadian Sport Institute Pacific, University of Victoria, University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Victoria
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8W 2Y2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trent Stellingwerff, Ph.D.
Phone
250-220-6674
Email
tstellingwerff@csipacific.ca
First Name & Middle Initial & Last Name & Degree
Ida A Heikura, Ph.D.
Phone
778-587-8508
Email
iheikura@csipacific.ca
First Name & Middle Initial & Last Name & Degree
Trent Stellingwerff, Ph.D.
First Name & Middle Initial & Last Name & Degree
Ida A Heikura, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared with researchers outside of the study team.

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Relative Energy Deficiency in Sport Multicenter Study

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