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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05567211
Enrollment
50
Registered
2022-10-05
Start date
2022-09-01
Completion date
2023-10-30
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antioxidative Stress, Energy Deficit Syndrome, Female Athlete Triad, Mediterranean Diet, Nutritional Disorder, Red Fruits, Sports Physical Therapy

Brief 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).

Interventions

OTHERFree 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.

OTHERPersonalized 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.

OTHERPersonalized 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.

Sponsors

University of Alicante
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stress12 weeksMeasurement of oxidative stress by pentane by exhaled air
Weight12 weeksWeight evaluation using a digital scale
Anthropometric assessment - Height12 weeksRestricted profile proposed by the International Society for the Development of Cineanthropometry.
Fat mass12 weeksThrough anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Faulkner formula will be used.
Muscular mass12 weeksThrough anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. Lee's formula will be used.
Bone mass12 weeksThrough anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Rocha formula will be used.
Hydratation12 weeksUrine density will be measured with Refractometer.
Menstrual cycle12 weeksUsing 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 symptoms12 weeksThe 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.)12 weeksIn cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram
Blood pressure12 weeksUsing an OMROM upper arm blood pressure monitor.
Cholesterol in blood12 weeksCholesterol by blood test
Strength12 weeksAll participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.
Creatin-Kinase in blood12 weeksCreatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.
Perception of quality of life12 weeksUsing 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 state12 weeksProfile 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 behavior12 weeksEating 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026