Relative Energy Deficiency in Sport Multicenter Study

NCT04766203 | Unknown

• 1 other identifier: RED-S multicenter 2020-22
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (25)

• 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 Outcomes (19)

• Body composition

  Baseline and possibly change after 6 months for a subset of athletes

• Complete blood count

  Baseline and possibly change after 6 months for a subset of athletes

• Insulin concentrations

  Baseline and possibly change after 6 months for a subset of athletes

• Glucose concentrations

  Baseline and possibly change after 6 months for a subset of athletes

• Cortisol concentrations

  Baseline and possibly change after 6 months for a subset of athletes

Study Arms (4)

Global screening of high-performance athletes for REDS

NO INTERVENTION

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.

Basic screening of Canadian high-performance athletes for REDS

NO INTERVENTION

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.

Advanced screening of Canadian high-performance athletes for REDS

NO INTERVENTION

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.

Treatment of Canadian athletes with REDS: a holistic intervention arm

EXPERIMENTAL

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

Interventions

Treatment of REDS using a holistic treatment arm BEHAVIORAL

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.

Treatment of Canadian athletes with REDS: a holistic intervention arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 15 years old
• Pregnant

Sponsors & Collaborators

• Trent Stellingwerff: lead
• Mitacs: collaborator
• University of British Columbia: collaborator

Study Sites (1)

University of Victoria

Victoria, British Columbia, V8W 2Y2, Canada

RECRUITING

MeSH Terms

Conditions

Nutrition Disorders; Athletic Injuries; Endocrine System Diseases; Feeding and Eating Disorders; Sleep Hygiene; Cardiovascular Abnormalities; Fractures, Bone; Bone Diseases, Metabolic; Body Weight Changes

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Wounds and Injuries; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Health Behavior; Behavior; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Body Weight

Study Officials

• Trent Stellingwerff, Ph.D.

  Canadian Sport Institute Pacific, University of Victoria, University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trent Stellingwerff, Ph.D.

CONTACT

250-208-6674; tstellingwerff@csipacific.ca

Ida A Heikura, Ph.D.

CONTACT

778-587-8508; iheikura@csipacific.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Performance Solutions, Innovation & Research for Canadian Sport Institute Pacific (CSI Pacific) Adjunct Faculty - Exercise Science, Physical & Health Education (EPHE), University of Victoria (UVic)

Model Details: 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

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 23, 2021
• Study Start: May 5, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: June 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)