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

Not Applicable

Completed

• Conditions: Female Athlete Triad; Sports Physical Therapy; Energy Deficit Syndrome; Mediterranean Diet; Antioxidative Stress; Red Fruits; Nutritional Disorder
• Interventions: Other: Free use of the virtual platform.; Other: Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application.; Other: Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.

• Registration Number: NCT05567211
• Lead Sponsor: University of Alicante

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-05
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group with free use of the virtual platform	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	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	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.

Primary Outcome Measures

Name	Time	Method
Fat mass	12 weeks	Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Faulkner formula will be used.
Hydratation	12 weeks	Urine density will be measured with Refractometer.
Oxidative stress	12 weeks	Measurement of oxidative stress by pentane by exhaled air
Muscular mass	12 weeks	Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. Lee's formula will be used.
Bone mass	12 weeks	Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Rocha formula will be used.
Anthropometric assessment - Height	12 weeks	Restricted profile proposed by the International Society for the Development of Cineanthropometry.
Cholesterol in blood	12 weeks	Cholesterol by blood test
Creatin-Kinase in blood	12 weeks	Creatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.
Weight	12 weeks	Weight evaluation using a digital scale
Maximal oxygen uptake (VO2 max.)	12 weeks	In cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram
Strength	12 weeks	All participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.
Perception of quality of life	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.
Menstrual cycle	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	12 weeks	The questionnaire on irritable bowel syndrome and symptom management among endurance athletes will be used; https://pubmed.ncbi.nlm.nih.gov/30232638/
Mood state	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	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.
Blood pressure	12 weeks	Using an OMROM upper arm blood pressure monitor.

Trial Locations

Locations (1)

Alejandro Martínez Rodriguez; 🇪🇸 Elche, Alicante, Spain