SUSTAINA Study: Effects of Sustainable Diet and Therapeutic Exercise on Health in Young Athletes (SUSTAINA)
27 de abril de 2026 actualizado por: Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
Research and Development of New Sustainable Dietary and Nutritional Programs and Therapeutic Exercise for the Prevention of Metabolic and Musculoskeletal Disorders
The SUSTAINA study aims to evaluate the effects of sustainable dietary programs combined with individualized therapeutic exercise on metabolic health, body composition, and musculoskeletal function in young athletes.
Participants will be randomly assigned to different intervention groups receiving tailored exercise training and nutritional guidance based on Mediterranean diet principles.
The study will assess physiological, anthropometric, and functional outcomes to identify effective strategies for preventing metabolic and musculoskeletal disorders.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Descripción detallada
This study is a randomized controlled trial designed to investigate the impact of combined dietary and exercise interventions on health outcomes in young athletes. Participants will be allocated into different groups, including a control group and intervention groups receiving structured therapeutic exercise programs and personalized nutritional strategies based on sustainable Mediterranean diet principles.
Measurements will include body composition, metabolic parameters, physical performance, and musculoskeletal function. The intervention is expected to provide evidence-based strategies to prevent metabolic and musculoskeletal disorders in physically active populations.
Tipo de estudio
Intervencionista
Inscripción (Actual)
70
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Alicante
-
Elche, Alicante, España, 03202
- European Institute Of Exercise and Health
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Age between 14 and 25 years
- Regular participation in organized physical activity (≥4 days per week)
- Healthy individuals without diagnosed metabolic or musculoskeletal disorders
- Ability to participate in physical exercise programs
- Written informed consent provided by the participant or legal guardian (for minors)
Exclusion Criteria:
- Presence of diagnosed metabolic disease (e.g., diabetes, cardiovascular disease)
- Musculoskeletal injury or condition that prevents participation in exercise
- Any medical condition contraindicating physical activity
- Use of medication or treatment that may affect metabolic or physical performance outcomes
- Failure to comply with study procedures or intervention protocols
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Arm 1: Control Group
Nutritional intervention only (no structured exercise).
Participants receive a personalized dietary intervention based on Mediterranean diet principles, without participation in a structured exercise program.
|
Personalized dietary program based on sustainable Mediterranean diet principles, adapted to individual energy and nutritional requirements.
|
|
Experimental: Arm 2: Traditional resistance training (hypertrophy) + nutritional intervention
Participants perform a hypertrophy-focused resistance training program combined with a personalized dietary intervention.
|
Personalized dietary program based on sustainable Mediterranean diet principles, adapted to individual energy and nutritional requirements.
Traditional resistance training program including hypertrophy and strength-based exercises using guided machines and free weights.
|
|
Experimental: Arm 3: Explosive strength training + nutritional intervention
Participants perform an explosive strength training program combined with a personalized dietary intervention.
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Personalized dietary program based on sustainable Mediterranean diet principles, adapted to individual energy and nutritional requirements.
High-intensity strength training focused on explosive movements using free weights.
|
|
Experimental: Arm 4: Functional training + nutritional intervention
Participants perform a functional training program using alternative materials combined with a personalized dietary intervention.
|
Personalized dietary program based on sustainable Mediterranean diet principles, adapted to individual energy and nutritional requirements.
Exercise program based on functional movements using alternative training materials.
|
|
Experimental: Arm 5: Isoinertial training + nutritional intervention
Participants perform an isoinertial resistance training program combined with a personalized dietary intervention.
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Personalized dietary program based on sustainable Mediterranean diet principles, adapted to individual energy and nutritional requirements.
Resistance training program using isoinertial devices with an emphasis on eccentric load.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in fat mass
Periodo de tiempo: Baseline to 9 months
|
Assessment of fat mass using dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis.
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Baseline to 9 months
|
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Change in lean body mass
Periodo de tiempo: Baseline to 9 months
|
Assessment of lean body mass using dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis.
|
Baseline to 9 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in blood glucose levels
Periodo de tiempo: Baseline to 9 months
|
Measurement of blood glucose levels using a portable biochemical analyzer.
|
Baseline to 9 months
|
|
Change in triglyceride levels
Periodo de tiempo: Baseline to 9 months
|
Assessment of triglyceride levels using a portable biochemical analyzer.
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Baseline to 9 months
|
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Change in bone mineral content
Periodo de tiempo: Baseline to 9 months
|
Assessment of bone mineral content using dual-energy X-ray absorptiometry (DXA).
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Baseline to 9 months
|
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Change in total cholesterol levels
Periodo de tiempo: Baseline to 9 months
|
Assessment of total cholesterol levels using a portable biochemical analyzer.
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Baseline to 9 months
|
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Change in handgrip strength
Periodo de tiempo: Baseline and 9 months
|
Assessment of upper body isometric strength using a handgrip dynamometer.
Measured in kilograms (kg)
|
Baseline and 9 months
|
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Change in lower body strength (countermovement jump height)
Periodo de tiempo: Baseline and 9 months
|
Assessment of lower body strength using countermovement jump (CMJ) height measured with a contact platform (cm).
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Baseline and 9 months
|
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Change in sprint performance
Periodo de tiempo: Baseline and 9 months
|
Assessment of sprint performance using 10-30 meter sprint tests measured with photocell timing systems.
Measured in seconds (s)
|
Baseline and 9 months
|
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Change in endurance capacity (Yo-Yo Intermittent Recovery Test Level 1)
Periodo de tiempo: Baseline and 9 months
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Assessment of endurance capacity using the Yo-Yo Intermittent Recovery Test Level 1, expressed as total distance covered (meters).
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Baseline and 9 months
|
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Change in functional movement (Functional Movement Screen score)
Periodo de tiempo: Baseline and 9 months
|
Assessment of functional movement using the Functional Movement Screen (FMS), scored from 0 to 21 points, where higher scores indicate better movement quality and lower injury risk.
|
Baseline and 9 months
|
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Change in joint range of motion
Periodo de tiempo: Baseline and 9 months
|
Assessment of joint range of motion using goniometric measurements.
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Baseline and 9 months
|
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Change in urine specific gravity
Periodo de tiempo: Baseline and 9 months
|
Assessment of hydration status using urine specific gravity measured by refractometry.
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Baseline and 9 months
|
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Change in hydration status (urine color scale)
Periodo de tiempo: Baseline and 9 months
|
Assessment of hydration status using a validated urine color scale ranging from 1 to 8, where lower values indicate better hydration status and higher values indicate dehydration.
|
Baseline and 9 months
|
|
Change in blood pressure
Periodo de tiempo: Baseline and 9 months
|
Measurement of systolic and diastolic blood pressure using a digital sphygmomanometer.
|
Baseline and 9 months
|
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Change in basal metabolic rate
Periodo de tiempo: Baseline and 9 months
|
Assessment of basal metabolic rate using indirect calorimetry.
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Baseline and 9 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2026
Finalización primaria (Estimado)
30 de junio de 2026
Finalización del estudio (Estimado)
30 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2026
Publicado por primera vez (Actual)
5 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UA-2026-02-19_3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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