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

NCT ID: NCT05567211

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type PLACEBO_COMPARATOR

Free use of the virtual platform.

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Personalized nutritional planning based on the Mediterranean diet + physical exercise + use of mobile application.

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Personalized nutritional planning with an extra intake of berries + physical exercise + use of mobile application.

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alicante

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Alejandro Martínez-Rodríguez

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alejandro Martínez Rodriguez

Elche, Alicante, Spain

Site Status

Countries

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Spain

Other Identifiers

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UA-2021-03-11

Identifier Type: -

Identifier Source: org_study_id