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- Ensaio Clínico NCT07567066
SUSTAINA Study: Effects of Sustainable Diet and Therapeutic Exercise on Health in Young Athletes (SUSTAINA)
Research and Development of New Sustainable Dietary and Nutritional Programs and Therapeutic Exercise for the Prevention of Metabolic and Musculoskeletal Disorders
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Alicante
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Elche, Alicante, Espanha, 03202
- European Institute Of Exercise and Health
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
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Personalized dietary program based on sustainable Mediterranean diet principles, adapted to individual energy and nutritional requirements.
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Experimental: Arm 2: Traditional resistance training (hypertrophy) + nutritional intervention
Participants perform a hypertrophy-focused 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.
Traditional resistance training program including hypertrophy and strength-based exercises using guided machines and free weights.
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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.
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Experimental: Arm 4: Functional training + nutritional intervention
Participants perform a functional training program using alternative materials 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.
Exercise program based on functional movements using alternative training materials.
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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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in fat mass
Prazo: 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
Prazo: Baseline to 9 months
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Assessment of lean body mass using dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis.
|
Baseline to 9 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in blood glucose levels
Prazo: Baseline to 9 months
|
Measurement of blood glucose levels using a portable biochemical analyzer.
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Baseline to 9 months
|
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Change in triglyceride levels
Prazo: Baseline to 9 months
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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
Prazo: Baseline to 9 months
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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
Prazo: Baseline to 9 months
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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
Prazo: 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)
Prazo: Baseline and 9 months
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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
Prazo: 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)
Prazo: Baseline and 9 months
|
Assessment of endurance capacity using the Yo-Yo Intermittent Recovery Test Level 1, expressed as total distance covered (meters).
|
Baseline and 9 months
|
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Change in functional movement (Functional Movement Screen score)
Prazo: Baseline and 9 months
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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.
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Baseline and 9 months
|
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Change in joint range of motion
Prazo: Baseline and 9 months
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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
Prazo: Baseline and 9 months
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Assessment of hydration status using urine specific gravity measured by refractometry.
|
Baseline and 9 months
|
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Change in hydration status (urine color scale)
Prazo: 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
|
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Change in blood pressure
Prazo: 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
Prazo: Baseline and 9 months
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Assessment of basal metabolic rate using indirect calorimetry.
|
Baseline and 9 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UA-2026-02-19_3
Plano para dados de participantes individuais (IPD)
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