Skip to main content
OpenTrials
Completed

NCT Number: NCT05567211

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Female Athlete Triad Antioxidative Stress Energy Deficit Syndrome Feeding and Eating Disorders Female Athlete Triad Syndrome Mediterranean Diet Mental Disorders Nutrition Disorders Nutritional Disorder Nutritional and Metabolic Diseases Red Fruits Relative Energy Deficiency in Sport Sports Physical Therapy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alejandro Martínez Rodriguez

Elche, Alicante, 03203, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Oxidative stress

    Time frame: 12 weeks

    Measurement of oxidative stress by pentane by exhaled air

  2. Weight

    Time frame: 12 weeks

    Weight evaluation using a digital scale

  3. Anthropometric assessment - Height

    Time frame: 12 weeks

    Restricted profile proposed by the International Society for the Development of Cineanthropometry.

  4. 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.

  5. 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.

  6. 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.

  7. Hydratation

    Time frame: 12 weeks

    Urine density will be measured with Refractometer.

  8. 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.

  9. 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/

  10. Maximal oxygen uptake (VO2 max.)

    Time frame: 12 weeks

    In cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram

  11. Blood pressure

    Time frame: 12 weeks

    Using an OMROM upper arm blood pressure monitor.

  12. Cholesterol in blood

    Time frame: 12 weeks

    Cholesterol by blood test

  13. Strength

    Time frame: 12 weeks

    All participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.

  14. Creatin-Kinase in blood

    Time frame: 12 weeks

    Creatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.

  15. 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.

  16. 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.

  17. 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.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition: Oxidative Stress and Other Physiological, Physical and Psychological Alterations.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.