Health, SubjectiveNCT04766203
Relative Energy Deficiency in Sport Multicenter Study
A study testing Treatment of REDS using a holistic treatment arm in people with Health, Subjective and Nutrition Disorders, run by Trent Stellingwerff at 1 site in Canada.
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%. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective, Nutrition Disorders, Athletic Injuries
- What is being tested?
- Treatment of REDS using a holistic treatment arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under 15 years old
- Pregnant
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Victoria
Victoria, British Columbia, V8W 2Y2
Trent Stellingwerff, Ph.D., 250-220-6674, tstellingwerff@csipacific.ca
Ida A Heikura, Ph.D., 778-587-8508, iheikura@csipacific.ca
About this study
Official title: 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.
Read the 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.)
- Conditions
- Health, Subjective, Nutrition Disorders, Athletic Injuries, Hormone Disturbance, Exercise-related Amenorrhea, Eating Disorders
- Being tested
- Treatment of REDS using a holistic treatment arm
- Medical subject headings
- Nutrition Disorders, Athletic Injuries, Endocrine System Diseases, Feeding and Eating Disorders, Sleep Hygiene, Cardiovascular Abnormalities, Fractures, Bone, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of REDS using a holistic treatment armBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Treatment of REDS using a holistic treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
REDS clinical assessment tool and REDS risk score
a combination of validated and semi-validated questionnaires
Measured: 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
Measured: Baseline and possibly change after 6 months for a subset of athletes
Triiodothyronine concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Estrogen concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Testosterone concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Luteinizing hormone concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Follicle-stimulating hormone concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Sex-hormone binding globulin concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Hemoglobin concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Ferritin concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Serum iron concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Total iron binding capacity
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Iron saturation
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Total cholesterol concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
LDL cholesterol concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
HDL cholesterol concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Triglycerides concentrations
Venous blood samples
Measured: 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
Measured: Baseline
Resting metabolic rate
Assessment done with a metabolic cart by collecting respiratory gases
Measured: Baseline and possibly change after 6 months for a subset of athletes
Aerobic capacity
maximal oxygen uptake test
Measured: Baseline and possibly change after 6 months for a subset of athletes
Strength
Maximal strength tests
Measured: Baseline and possibly change after 6 months for a subset of athletes
Insulin like growth factor 1 concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Resting heart rate
Heart rate monitor (Polar electro)
Measured: Baseline and possibly change after 6 months for a subset of athletes
Blood pressure (systolic and diastolic)
Blood pressure monitor
Measured: Baseline and possibly change after 6 months for a subset of athletes
Bone stress injury history
online questionnaire on type and number of injuries
Measured: Baseline and possibly change after 6 months for a subset of athletes
Secondary outcomes (19)
Body composition
Via DXA or skinfold calipers
Measured: Baseline and possibly change after 6 months for a subset of athletes
Complete blood count
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Insulin concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Glucose concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Cortisol concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
Prolactin concentrations
Venous blood samples
Measured: Baseline and possibly change after 6 months for a subset of athletes
25(OH)D concentrations
Venous blood samples
Measured: 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
Measured: 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
Measured: Baseline and possibly change after 6 months for a subset of athletes
Sleep hygiene
Athlete Sleep Screening Questionnaire (higher scores reflect sleep impairments)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and possibly change after 6 months for a subset of athletes
Mood state
Brunel Mood Scales (higher scores reflect higher mood disturbance)
Measured: 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)
Measured: Baseline and possibly change after 6 months for a subset of athletes
History of weight change
online questionnaire
Measured: Baseline and possibly change after 6 months for a subset of athletes
History of anemia
online questionnaire
Measured: 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
Measured: Individualised but likely 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start5 May 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trent Stellingwerff
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, University of British Columbia
- Responsible party
- Sponsor-investigator, Trent Stellingwerff, University of Victoria
- Investigators
- Trent Stellingwerff, Ph.D., Principal investigator, Canadian Sport Institute Pacific, University of Victoria, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766203
- Sponsor's protocol ID
- RED-S multicenter 2020-22
- Status last verified
- Jun 2021
- First submitted
- 16 Feb 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with researchers outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Energy Deficiency in Sport (RED-S) in International and Canadian High Performance Athletes: Prevalence, Health and Performance Implications
- ClinicalTrials.gov ID
- NCT04766203
- Acronym / sponsor ID
- RED-S multicenter 2020-22
- Conditions
- Health, Subjective, Nutrition Disorders, Athletic Injuries, Hormone Disturbance, Exercise-related Amenorrhea, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Trent StellingwerffUniversity, hospital or other
- Collaborators
- Mitacs, University of British Columbia
- Study start
- 5 May 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Treatment of REDS using a holistic treatment armIn 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Under 15 years old
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of REDS using a holistic treatment armThis 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. | Behavioural | Treatment of Canadian athletes with REDS: a holistic intervention arm |
Primary outcome
REDS clinical assessment tool and REDS risk score
Time frame: Baseline and possibly change after 6 months for a subset of athletes
a combination of validated and semi-validated questionnaires
Menstrual function in females
Time frame: 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
Triiodothyronine concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Estrogen concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Testosterone concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Luteinizing hormone concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Follicle-stimulating hormone concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Sex-hormone binding globulin concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Hemoglobin concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Ferritin concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Serum iron concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Total iron binding capacity
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Iron saturation
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Total cholesterol concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
LDL cholesterol concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
HDL cholesterol concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Triglycerides concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Bone mineral density
Time frame: Baseline
Dual energy x ray scan of lumbar spine and femoral neck bone density
Resting metabolic rate
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Assessment done with a metabolic cart by collecting respiratory gases
Aerobic capacity
Time frame: Baseline and possibly change after 6 months for a subset of athletes
maximal oxygen uptake test
Strength
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Maximal strength tests
Insulin like growth factor 1 concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Venous blood samples
Resting heart rate
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Heart rate monitor (Polar electro)
Blood pressure (systolic and diastolic)
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Blood pressure monitor
Bone stress injury history
Time frame: Baseline and possibly change after 6 months for a subset of athletes
online questionnaire on type and number of injuries
19 secondary outcomes
Body composition
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Complete blood count
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Insulin concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Glucose concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Cortisol concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Prolactin concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
25(OH)D concentrations
Time frame: Baseline and possibly change after 6 months for a subset of athletes
illness history
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Soft-tissue injury history
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Sleep hygiene
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Mental health
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Male athlete health
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Gut health
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Cardiac health
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Mood state
Time frame: Baseline and possibly change after 6 months for a subset of athletes
Eating disorder assessment
Time frame: Baseline and possibly change after 6 months for a subset of athletes
History of weight change
Time frame: Baseline and possibly change after 6 months for a subset of athletes
History of anemia
Time frame: Baseline and possibly change after 6 months for a subset of athletes
REDS treatment arm
Time frame: Individualised but likely 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No. No data will be shared with researchers outside of the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trent Stellingwerff, Ph.D. principal investigator
Canadian Sport Institute Pacific, University of Victoria, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of REDS using a holistic treatment arm in people with Health, Subjective and Nutrition Disorders, run by Trent Stellingwerff at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trent Stellingwerff, Ph.D. (250-208-6674, tstellingwerff@csipacific.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REDS clinical assessment tool and REDS risk score (time frame: Baseline and possibly change after 6 months for a subset of athletes). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.