- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Alicante
-
Elche, Alicante, Spanien, 03202
- European Institute Of Exercise and Health
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in fat mass
Tidsramme: Baseline to 9 months
|
Assessment of fat mass using dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis.
|
Baseline to 9 months
|
|
Change in lean body mass
Tidsramme: Baseline to 9 months
|
Assessment of lean body mass using dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis.
|
Baseline to 9 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in blood glucose levels
Tidsramme: Baseline to 9 months
|
Measurement of blood glucose levels using a portable biochemical analyzer.
|
Baseline to 9 months
|
|
Change in triglyceride levels
Tidsramme: Baseline to 9 months
|
Assessment of triglyceride levels using a portable biochemical analyzer.
|
Baseline to 9 months
|
|
Change in bone mineral content
Tidsramme: 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
Tidsramme: Baseline to 9 months
|
Assessment of total cholesterol levels using a portable biochemical analyzer.
|
Baseline to 9 months
|
|
Change in handgrip strength
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline and 9 months
|
Assessment of joint range of motion using goniometric measurements.
|
Baseline and 9 months
|
|
Change in urine specific gravity
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline and 9 months
|
Measurement of systolic and diastolic blood pressure using a digital sphygmomanometer.
|
Baseline and 9 months
|
|
Change in basal metabolic rate
Tidsramme: Baseline and 9 months
|
Assessment of basal metabolic rate using indirect calorimetry.
|
Baseline and 9 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UA-2026-02-19_3
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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