Relative Energy Deficiency in SportNCT05649267
Using Energy Availability as a Strategy to Explore the Effects of Relative Energy Deficiency in Sport on Athletes
An observational study of Relative Energy Deficiency in Sport, run by Chen Ming You at 1 site in Taiwan.
Trial summary
The goal of this type of study:clinical trial is to test, compare etc. In describe participant population health conditions. Participants will diet record,maintain training and life. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Relative Energy Deficiency in Sport
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 May 2022to 9 Aug 2023
- Phase
- Observational
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Judoka
Who may be able to join
- In the past year, the daily training frequency is ≥4 times/week, and each time is at least 2 hours, and there are specific special trainers
Who cannot join
- smoke
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Sport University
Taoyuan
YI JU HSU, 03-3283201 ext. 2604, ruby780202@ntsu.edu.tw
About this study
Official title: Using Energy Availability as a Strategy to Explore the Effects of Relative Energy Deficiency in Sport (RED-S) on Athletes' Physiological Function, Health, and Performance
The goal of this type of study:clinical trial is to test, compare etc. In describe participant population health conditions. Participants will diet record,maintain training and life.
Read the detailed description
Relative energy deficiency in sport (RED-S) can negatively affect the health and performance of both male and female athletes. The underlying etiology of RED-S is low energy availability (LEA), which occurs when there is insufficient dietary energy intake to meet exercise energy expenditure. This syndrome refers to impaired physiological function, including metabolic rate, menstrual function, bone health, immunity, protein synthesis, and cardiovascular health. Strategies to support athlete health and training energy availability are an integral part of optimizing training outcomes and preparing for competition. This project aims to investigate the prevalence of RED-S among Taiwanese athletes by recruiting athletes of different age groups and to find the relevance of dietary risk factors to enhance energy availability. This project intends to recruit athletes in aesthetic sports and weight-sensitive sports to study the prevalence of RED-S in different training periods, and to find out the relationship between the possible dietary risk factors and the improvement of energy availability, and to understand whether the strategy of improving energy availability through the concept of nutritional supplements has a positive effect on the relative energy deficiency of athletes. In the first year of this study, the prevalence of relative energy deficits, dietary risk factors in pre-season, competition and off-season will be studied for aesthetic sport and weight-sensitive sport athletes, and relevant biological indicators will be searched. In the second year of this study, the effect of carbohydrates and proteins or specific nutrients as energy availability strategies on low energy availability animal physiological function, exercise performance and overall health status will be investigated. In the third year of this sudy, the effects of carbohydrate and protein supplementation with specific nutrients as energy availability strategies on athletes' physical function, athletic performance, and overall health status during high-relative energy-deficient training will be explored. It is hoped that through the successful implementation of this research project, the results can be applied to personalized dietary planning and ensure that minimizing adverse risk factors for athletes during critical periods, which is the most important key to maintaining good health, performing at their best in training and competition, and winning the highest honor for their country on the playing field.
Keywords: Energy availability, Relative energy deficiency in sport, Low energy availability risk factors, Carbohydrate availability, Protein availability
- Conditions
- Relative Energy Deficiency in Sport
- Medical subject headings
- Relative Energy Deficiency in Sport
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition Analysis
DEXA:bone mass density
Measured: 2022/10/29~2023/07/29
DEXA:Fat Free Mass
Body Bone Composition Analysis
Measured: 2022/10/29~2023/07/29
Inbody:Fat Free Mass
Body Composition Analysis
Measured: 2022/10/29~2023/07/29
Inbody:Skeletal Muscle Mass.
Body Composition Analysis
Measured: 2022/10/29~2023/07/29
Inbody:Body Fat Mass
Body Composition Analysis
Measured: 2022/10/29~2023/07/29
Inbody:body weight
Body Composition Analysis
Measured: 2022/10/29~2023/07/29
4 days diet record
Diet Record
Measured: 2022/10/29~2023/07/29
Diet Recordcaculate Energy Intake.
Diet Record
Measured: 2022/10/29~2023/07/29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start9 May 2022
- Primary completion9 May 2023 (estimated)
- Study completion9 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative Energy Deficiency in SportStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Ming You
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Ming You, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649267
- Sponsor's protocol ID
- IRB-3-R-026-1.1
- Status last verified
- Jan 2023
- First submitted
- 23 Nov 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Energy Availability as a Strategy to Explore the Effects of Relative Energy Deficiency in Sport (RED-S) on Athletes' Physiological Function, Health, and Performance
- ClinicalTrials.gov ID
- NCT05649267
- Acronym / sponsor ID
- IRB-3-R-026-1.1
- Conditions
- Relative Energy Deficiency in Sport
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chen Ming YouUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 9 May 2023 (estimated)
- Study completion
- 9 Aug 2023 (estimated)
- First posted
- 14 Dec 2022 (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.
The goal of this type of study:clinical trial is to test, compare etc. In describe participant population health conditions. Participants will diet record,maintain training and life.
Detailed description
Relative energy deficiency in sport (RED-S) can negatively affect the health and performance of both male and female athletes. The underlying etiology of RED-S is low energy availability (LEA), which occurs when there is insufficient dietary energy intake to meet exercise energy expenditure. This syndrome refers to impaired physiological function, including metabolic rate, menstrual function, bone health, immunity, protein synthesis, and cardiovascular health. Strategies to support athlete health and training energy availability are an integral part of optimizing training outcomes and preparing for competition. This project aims to investigate the prevalence of RED-S among Taiwanese athletes by recruiting athletes of different age groups and to find the relevance of dietary risk factors to enhance energy availability. This project intends to recruit athletes in aesthetic sports and weight-sensitive sports to study the prevalence of RED-S in different training periods, and to find out the relationship between the possible dietary risk factors and the improvement of energy availability, and to understand whether the strategy of improving energy availability through the concept of nutritional supplements has a positive effect on the relative energy deficiency of athletes. In the first year of this study, the prevalence of relative energy deficits, dietary risk factors in pre-season, competition and off-season will be studied for aesthetic sport and weight-sensitive sport athletes, and relevant biological indicators will be searched. In the second year of this study, the effect of carbohydrates and proteins or specific nutrients as energy availability strategies on low energy availability animal physiological function, exercise performance and overall health status will be investigated. In the third year of this sudy, the effects of carbohydrate and protein supplementation with specific nutrients as energy availability strategies on athletes' physical function, athletic performance, and overall health status during high-relative energy-deficient training will be explored. It is hoped that through the successful implementation of this research project, the results can be applied to personalized dietary planning and ensure that minimizing adverse risk factors for athletes during critical periods, which is the most important key to maintaining good health, performing at their best in training and competition, and winning the highest honor for their country on the playing field.
Keywords: Energy availability, Relative energy deficiency in sport, Low energy availability risk factors, Carbohydrate availability, Protein availability
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Judoka
Key inclusion criteria (1 listed)
- In the past year, the daily training frequency is ≥4 times/week, and each time is at least 2 hours, and there are specific special trainers
Key exclusion criteria (1 listed)
- smoke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Composition Analysis
Time frame: 2022/10/29~2023/07/29
DEXA:bone mass density
DEXA:Fat Free Mass
Time frame: 2022/10/29~2023/07/29
Body Bone Composition Analysis
Inbody:Fat Free Mass
Time frame: 2022/10/29~2023/07/29
Body Composition Analysis
Inbody:Skeletal Muscle Mass.
Time frame: 2022/10/29~2023/07/29
Body Composition Analysis
Inbody:Body Fat Mass
Time frame: 2022/10/29~2023/07/29
Body Composition Analysis
Inbody:body weight
Time frame: 2022/10/29~2023/07/29
Body Composition Analysis
4 days diet record
Time frame: 2022/10/29~2023/07/29
Diet Record
Diet Recordcaculate Energy Intake.
Time frame: 2022/10/29~2023/07/29
Diet Record
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relative Energy Deficiency in Sport, run by Chen Ming You at 1 site in Taiwan.
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 1 inclusion and 1 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 Feb 2023. 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 Taiwan. 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 Hsu YI JU, A.P. (03-3283201 ext. 2604, ruby780202@ntsu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition Analysis (time frame: 2022/10/29~2023/07/29). The study lists 8 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 Feb 2023.