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.

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 Overview

• Status: Completed
• Conditions: Sports Physical Therapy; Antioxidative Stress; Nutritional Disorder; Female Athlete Triad; Mediterranean Diet; Energy Deficit Syndrome; Red Fruits
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ALEJANDRO MARTINEZ, Nutrition and Dietetics.; Phone Number: 696210163; Email: amartinezrodriguez@gcloud.ua.es

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Alejandro Martínez Rodríguez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Will receive basic recommendations from the World Health Organization on healthy eating and physical activity.
Placebo Comparator: Control group with 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.	Other: 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.
Active Comparator: Intervention group with Mediterranean diet and physical exercise planning; 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.	Other: 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.
Active Comparator: Intervention group with red berries and physical exercise planning; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative stress	Measurement of oxidative stress by pentane by exhaled air	12 weeks
Weight	Weight evaluation using a digital scale	12 weeks
Anthropometric assessment - Height	Restricted profile proposed by the International Society for the Development of Cineanthropometry.	12 weeks
Fat mass	Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Faulkner formula will be used.	12 weeks
Muscular mass	Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. Lee's formula will be used.	12 weeks
Bone mass	Through anthropometry. Restricted profile proposed by the International Society for the Development of Cineanthropometry. The Rocha formula will be used.	12 weeks
Hydratation	Urine density will be measured with Refractometer.	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.	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/	12 weeks
Maximal oxygen uptake (VO2 max.)	In cycloergometer and cardiorespiratory fitness test monitored with electrocardiogram	12 weeks
Blood pressure	Using an OMROM upper arm blood pressure monitor.	12 weeks
Cholesterol in blood	Cholesterol by blood test	12 weeks
Strength	All participants will perform a countermovement jump, using a contact platform. Higher values will mean better performance.	12 weeks
Creatin-Kinase in blood	Creatin-Kinase by blood test (milligrams/deciliters). High values may be a sign of overtraining.	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.	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.	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Alicante

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Feeding and Eating Disorders; Relative Energy Deficiency in Sport; Syndrome; Malnutrition; Nutrition Disorders; Female Athlete Triad Syndrome
• Other Study ID Numbers: UA-2021-03-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No