CompletedNot Applicable

Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition.

Spain50 participantsStarted 2022-09-01

Plain-language 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. 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).

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * (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. Exclusion Criteria: \- All individuals taking medication that could affect the results of the study will be excluded from the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oxidative stress

Timeframe: 12 weeks

Weight

Timeframe: 12 weeks

Anthropometric assessment - Height

Timeframe: 12 weeks

Fat mass

Timeframe: 12 weeks

Muscular mass

Timeframe: 12 weeks

Bone mass

Timeframe: 12 weeks

Hydratation

Timeframe: 12 weeks

Menstrual cycle

Timeframe: 12 weeks

Trial details

NCT IDNCT05567211

SponsorUniversity of Alicante

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Female Athlete Triad trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.