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

Sports Physical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567211
• Other study ID #: UA-2021-03-11
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: University of Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Female Athlete Triad
• Malnutrition
• Mediterranean Diet
• Nutrition Disorders
• Nutritional Disorder
• Sports Physical Therapy
• Syndrome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Alejandro Martínez Rodriguez	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

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