SUSTAINA Study: Effects of Sustainable Diet and Therapeutic Exercise on Health in Young Athletes (SUSTAINA)
27. april 2026 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
70
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alicante
-
Elche, Alicante, Spania, 03202
- European Institute Of Exercise and Health
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Ja
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2026
Primær fullføring (Antatt)
30. juni 2026
Studiet fullført (Antatt)
30. september 2026
Datoer for studieregistrering
Først innsendt
20. april 2026
Først innsendt som oppfylte QC-kriteriene
27. april 2026
Først lagt ut (Faktiske)
5. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UA-2026-02-19_3
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .