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

NCT05567211 | Completed

• 1 other identifier: UA-2021-03-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (17)

• 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

Study Arms (4)

Control group

NO INTERVENTION

Will receive basic recommendations from the World Health Organization on healthy eating and physical activity.

Control group with free use of the virtual platform

PLACEBO COMPARATOR

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.

Intervention group with Mediterranean diet and physical exercise planning

ACTIVE COMPARATOR

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.

Intervention group with red berries and physical exercise planning

ACTIVE COMPARATOR

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.

Interventions

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.

Control group with free use of the virtual platform

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.

Intervention group with Mediterranean diet and physical exercise planning

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.

Intervention group with red berries and physical exercise planning

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• \- All individuals taking medication that could affect the results of the study will be excluded from the study.

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

Alejandro Martínez Rodriguez

Elche, Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Female Athlete Triad Syndrome; Nutrition Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Relative Energy Deficiency in Sport; Feeding and Eating Disorders; Mental Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 5, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)