Female Athlete TriadNCT05567211
Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition.
A study testing Free use of the virtual platform., Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application. and Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application. in people with Female Athlete Triad and Energy Deficit Syndrome, run by University of Alicante at 1 site in Spain.
Trial summary
Energy Deficit Syndrome (RED-S) is the impairment of physiological functioning caused by relative energy deficiency and includes impaired metabolic rate, menstrual, endocrine, hematological, immunological, gastrointestinal, bone, psychological, developmental and cardiovascular function. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Athlete Triad, Energy Deficit Syndrome, Mediterranean Diet
- What is being tested?
- Free use of the virtual platform., Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application. and Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 30 Oct 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- (a) exercise at least 3 days/week,
- (b) not having any diagnosed chronic pathology or ailment that prevents physical exercise or following nutritional guidelines rich in antioxidants.
Who cannot join
- All individuals taking medication that could affect the results of the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition: Oxidative Stress and Other Physiological, Physical and Psychological Alterations.
Energy Deficit Syndrome (RED-S) is the impairment of physiological functioning caused by relative energy deficiency and includes impaired metabolic rate, menstrual, endocrine, hematological, immunological, gastrointestinal, bone, psychological, developmental and cardiovascular function. Eighty-seven percent of athletes show at least one symptom related to RED-S, with a higher prevalence in women. Treatment of RED-S preferably involves a multidisciplinary team of health professionals to address the complex interaction of nutrition, training, body image and performance. The main objective is to prevent energy deficit syndrome in female athletes in the province of Alicante through different training and diet protocols using a virtual platform. A 12-week single-blind randomized clinical trial with an intervention period and a control period (RCT) is proposed. The sports federations of the most representative practices in the province of Alicante will be selected by randomized sampling. The female athletes will be randomly divided into 4 groups (control group; control group with free use of the virtual platform; intervention group with Mediterranean diet and physical exercise planning; intervention group with red fruits and physical exercise planning).
- Conditions
- Female Athlete Triad, Energy Deficit Syndrome, Mediterranean Diet, Red Fruits, Antioxidative Stress, Nutritional Disorder
- Being tested
- Free use of the virtual platform., Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application., Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.
- Medical subject headings
- Female Athlete Triad Syndrome, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free use of the virtual platform.Other
Access to the virtual platform + general healthy eating and physical activity recommendations. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood.
Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application.Other
Access to the virtual platform + nutritional planning based on the Mediterranean diet + physical activity. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood.
Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.Other
Access to the virtual platform + nutritional planning with an extra supply of antioxidants using red berries + physical activity. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Will receive basic recommendations from the World Health Organization on healthy eating and physical activity. |
| Control group with free use of the virtual platform | Placebo comparator | The athletes, in addition to the recommendations indicated in the previous point, will have access to the virtual platform designed to voluntarily record the parameters they consider appropriate. Receives: Other: Free use of the virtual platform. |
| Intervention group with Mediterranean diet and physical exercise planning | Active comparator | They will receive nutritional plans adapted to their energy expenditure and based on Mediterranean diet. The physical exercise intervention will be based on 3 weekly sessions of 50 minutes of combined resistance and strength, deferred. Receives: Other: Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application. |
| Intervention group with red berries and physical exercise planning | Active comparator | They will also receive personalized nutritional plans with a diet rich in antioxidants obtained from red berries and the same physical exercise intervention as in the Mediterranean diet intervention group. Receives: Other: Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress
Measurement of oxidative stress by pentane by exhaled air
Measured: 12 weeks
Weight
Weight evaluation using a digital scale
Measured: 12 weeks
Anthropometric assessment - Height
Restricted profile proposed by the International Society for the Development of Cineanthropometry.
Measured: 12 weeks
Fat mass
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Faulkner formula will be used.
Measured: 12 weeks
Muscular mass
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. Lee's formula will be used.
Measured: 12 weeks
Bone mass
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Rocha formula will be used.
Measured: 12 weeks
Hydratation
Urine density will be measured with Refractometer.
Measured: 12 weeks
Menstrual cycle
Using the Relative Energy Deficiency in Sport (RED-S) Clinical Assessment Tool (CAT) questionnaire. It is a clinical assessment tool for the evaluation of athletes / active individuals suspected of having relative energy deficiency and for guiding return to play decisions.
Measured: 12 weeks
Gastrointestinal symptoms
The questionnaire on irritable bowel syndrome and symptom management among endurance athletes will be used; https://pubmed.ncbi.nlm.nih.gov/30232638/
Measured: 12 weeks
Maximal oxygen uptake (VO2 max.)
In cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram
Measured: 12 weeks
Blood pressure
Using an OMROM upper arm blood pressure monitor.
Measured: 12 weeks
Cholesterol in blood
Cholesterol by blood test
Measured: 12 weeks
Strength
All participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.
Measured: 12 weeks
Creatin-Kinase in blood
Creatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.
Measured: 12 weeks
Perception of quality of life
Using a Quality of Life Questionnaire (SF36). Quality of Life Questionnaire is a comprehensive questionnaire that covers various attributes of an individuals life. It covers a variety of demographic questions to get better quality data and information before analyzing the quality of life of an individual.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 12 weeks
Mood state
Profile of Mood State Questionnaire (POMS). The POMS questionnaire assesses six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. High vigor scores reflect a good mood or emotion, and low scores in the other subscales reflect a good mood or emotion.
Measured: 12 weeks
Eating behavior
Eating Behavior Questionnaire (EAT-26). It is used to identify the presence of "eating disorder risk" based on attitudes, feelings and behaviours related to eating. There are 26 self-report questions assessing general eating behaviour and five additional questions assessing risky behaviours. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder. Total scores 20 or above are considered to be in the clinical range.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Sep 2022
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Athlete TriadStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567211
- Sponsor's protocol ID
- UA-2021-03-11
- Status last verified
- Nov 2023
- First submitted
- 30 Sep 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition: Oxidative Stress and Other Physiological, Physical and Psychological Alterations.
- ClinicalTrials.gov ID
- NCT05567211
- Acronym / sponsor ID
- UA-2021-03-11
- Conditions
- Female Athlete Triad, Energy Deficit Syndrome, Mediterranean Diet, Red Fruits, Antioxidative Stress, Nutritional Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 5 Oct 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.
Energy Deficit Syndrome (RED-S) is the impairment of physiological functioning caused by relative energy deficiency and includes impaired metabolic rate, menstrual, endocrine, hematological, immunological, gastrointestinal, bone, psychological, developmental and cardiovascular function. Eighty-seven percent of athletes show at least one symptom related to RED-S, with a higher prevalence in women. Treatment of RED-S preferably involves a multidisciplinary team of health professionals to address the complex interaction of nutrition, training, body image and performance. The main objective is to prevent energy deficit syndrome in female athletes in the province of Alicante through different training and diet protocols using a virtual platform. A 12-week single-blind randomized clinical trial with an intervention period and a control period (RCT) is proposed. The sports federations of the most representative practices in the province of Alicante will be selected by randomized sampling. The female athletes will be randomly divided into 4 groups (control group; control group with free use of the virtual platform; intervention group with Mediterranean diet and physical exercise planning; intervention group with red fruits and physical exercise planning).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Will receive basic recommendations from the World Health Organization on healthy eating and physical activity. |
| Control group with free use of the virtual platform | Placebo comparator | Other: Free use of the virtual platform.The athletes, in addition to the recommendations indicated in the previous point, will have access to the virtual platform designed to voluntarily record the parameters they consider appropriate. |
| Intervention group with Mediterranean diet and physical exercise planning | Active comparator | Other: Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application.They will receive nutritional plans adapted to their energy expenditure and based on Mediterranean diet. The physical exercise intervention will be based on 3 weekly sessions of 50 minutes of combined resistance and strength, deferred. |
| Intervention group with red berries and physical exercise planning | Active comparator | Other: Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.They will also receive personalized nutritional plans with a diet rich in antioxidants obtained from red berries and the same physical exercise intervention as in the Mediterranean diet intervention group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- (a) exercise at least 3 days/week,
- (b) not having any diagnosed chronic pathology or ailment that prevents physical exercise or following nutritional guidelines rich in antioxidants.
Key exclusion criteria (1 listed)
- All individuals taking medication that could affect the results of the study will be excluded from the study.
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 |
|---|---|---|
| Free use of the virtual platform.Access to the virtual platform + general healthy eating and physical activity recommendations. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood. | Other | Control group with free use of the virtual platform |
| Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application.Access to the virtual platform + nutritional planning based on the Mediterranean diet + physical activity. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood. | Other | Intervention group with Mediterranean diet and physical exercise planning |
| Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.Access to the virtual platform + nutritional planning with an extra supply of antioxidants using red berries + physical activity. The platform will allow the registration of all the evolution, monitoring of nutritional and sports patterns (with activity bracelet), as well as oxidative stress, hydration, menstrual phase and mood. | Other | Intervention group with red berries and physical exercise planning |
Primary outcome
Oxidative stress
Time frame: 12 weeks
Measurement of oxidative stress by pentane by exhaled air
Weight
Time frame: 12 weeks
Weight evaluation using a digital scale
Anthropometric assessment - Height
Time frame: 12 weeks
Restricted profile proposed by the International Society for the Development of Cineanthropometry.
Fat mass
Time frame: 12 weeks
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Faulkner formula will be used.
Muscular mass
Time frame: 12 weeks
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. Lee's formula will be used.
Bone mass
Time frame: 12 weeks
Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Rocha formula will be used.
Hydratation
Time frame: 12 weeks
Urine density will be measured with Refractometer.
Menstrual cycle
Time frame: 12 weeks
Using the Relative Energy Deficiency in Sport (RED-S) Clinical Assessment Tool (CAT) questionnaire. It is a clinical assessment tool for the evaluation of athletes / active individuals suspected of having relative energy deficiency and for guiding return to play decisions.
Gastrointestinal symptoms
Time frame: 12 weeks
The questionnaire on irritable bowel syndrome and symptom management among endurance athletes will be used; https://pubmed.ncbi.nlm.nih.gov/30232638/
Maximal oxygen uptake (VO2 max.)
Time frame: 12 weeks
In cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram
Blood pressure
Time frame: 12 weeks
Using an OMROM upper arm blood pressure monitor.
Cholesterol in blood
Time frame: 12 weeks
Cholesterol by blood test
Strength
Time frame: 12 weeks
All participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.
Creatin-Kinase in blood
Time frame: 12 weeks
Creatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.
Perception of quality of life
Time frame: 12 weeks
Using a Quality of Life Questionnaire (SF36). Quality of Life Questionnaire is a comprehensive questionnaire that covers various attributes of an individuals life. It covers a variety of demographic questions to get better quality data and information before analyzing the quality of life of an individual.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Mood state
Time frame: 12 weeks
Profile of Mood State Questionnaire (POMS). The POMS questionnaire assesses six mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. High vigor scores reflect a good mood or emotion, and low scores in the other subscales reflect a good mood or emotion.
Eating behavior
Time frame: 12 weeks
Eating Behavior Questionnaire (EAT-26). It is used to identify the presence of "eating disorder risk" based on attitudes, feelings and behaviours related to eating. There are 26 self-report questions assessing general eating behaviour and five additional questions assessing risky behaviours. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder. Total scores 20 or above are considered to be in the clinical range.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free use of the virtual platform., Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application. and Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application. in people with Female Athlete Triad and Energy Deficit Syndrome, run by University of Alicante at 1 site in Spain.
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 2 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: finished, as of the sponsor's last update on 29 Nov 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress (time frame: 12 weeks). The study lists 17 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 29 Nov 2023.