SUSTAINA Study: Effects of Sustainable Diet and Therapeutic Exercise on Health in Young Athletes (SUSTAINA)
27 april 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
70
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Alicante
-
Elche, Alicante, Spanje, 03202
- European Institute Of Exercise and Health
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
|
Experimenteel: 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.
|
|
Experimenteel: Arm 3: Explosive strength training + nutritional intervention
Participants perform an explosive strength training program combined with a personalized dietary intervention.
|
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.
|
|
Experimenteel: 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.
|
|
Experimenteel: Arm 5: Isoinertial training + nutritional intervention
Participants perform an isoinertial 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.
Resistance training program using isoinertial devices with an emphasis on eccentric load.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in fat mass
Tijdsspanne: 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
Tijdsspanne: Baseline to 9 months
|
Assessment of lean body mass using dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis.
|
Baseline to 9 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in blood glucose levels
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline to 9 months
|
Assessment of bone mineral content using dual-energy X-ray absorptiometry (DXA).
|
Baseline to 9 months
|
|
Change in total cholesterol levels
Tijdsspanne: Baseline to 9 months
|
Assessment of total cholesterol levels using a portable biochemical analyzer.
|
Baseline to 9 months
|
|
Change in handgrip strength
Tijdsspanne: Baseline and 9 months
|
Assessment of upper body isometric strength using a handgrip dynamometer.
Measured in kilograms (kg)
|
Baseline and 9 months
|
|
Change in lower body strength (countermovement jump height)
Tijdsspanne: Baseline and 9 months
|
Assessment of lower body strength using countermovement jump (CMJ) height measured with a contact platform (cm).
|
Baseline and 9 months
|
|
Change in sprint performance
Tijdsspanne: 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
|
|
Change in endurance capacity (Yo-Yo Intermittent Recovery Test Level 1)
Tijdsspanne: 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
|
|
Change in functional movement (Functional Movement Screen score)
Tijdsspanne: 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
|
|
Change in joint range of motion
Tijdsspanne: Baseline and 9 months
|
Assessment of joint range of motion using goniometric measurements.
|
Baseline and 9 months
|
|
Change in urine specific gravity
Tijdsspanne: Baseline and 9 months
|
Assessment of hydration status using urine specific gravity measured by refractometry.
|
Baseline and 9 months
|
|
Change in hydration status (urine color scale)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline and 9 months
|
Assessment of basal metabolic rate using indirect calorimetry.
|
Baseline and 9 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2026
Primaire voltooiing (Geschat)
30 juni 2026
Studie voltooiing (Geschat)
30 september 2026
Studieregistratiedata
Eerst ingediend
20 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 april 2026
Eerst geplaatst (Werkelijk)
5 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
27 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UA-2026-02-19_3
Plan Individuele Deelnemersgegevens (IPD)
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NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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