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NCT Number: NCT07567066

SUSTAINA Study: Effects of Sustainable Diet and Therapeutic Exercise on Health in Young Athletes

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metabolic Health Behavior Body Composition Motor Activity Musculoskeletal Diseases Musculoskeletal Disorders (MSDs) Physical Fitness

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Institute Of Exercise and Health

Elche, Alicante, 03202, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral: Nutritional Intervention

Behavioral

Personalized dietary program based on sustainable Mediterranean diet principles, adapted to individual energy and nutritional requirements.

Conventional Strength Training

Other

Traditional resistance training program including hypertrophy and strength-based exercises using guided machines and free weights.

Explosive Strength Training

Other

High-intensity strength training focused on explosive movements using free weights.

Functional Training

Other

Exercise program based on functional movements using alternative training materials.

Isoinertial Training

Other

Resistance training program using isoinertial devices with an emphasis on eccentric load.

Primary outcomes

  1. Change in fat mass

    Time frame: Baseline to 9 months

    Assessment of fat mass using dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis.

  2. Change in lean body mass

    Time frame: Baseline to 9 months

    Assessment of lean body mass using dual-energy X-ray absorptiometry (DXA) and bioelectrical impedance analysis.

Secondary outcomes

  1. Change in blood glucose levels

    Time frame: Baseline to 9 months

    Measurement of blood glucose levels using a portable biochemical analyzer.

  2. Change in triglyceride levels

    Time frame: Baseline to 9 months

    Assessment of triglyceride levels using a portable biochemical analyzer.

  3. Change in bone mineral content

    Time frame: Baseline to 9 months

    Assessment of bone mineral content using dual-energy X-ray absorptiometry (DXA).

  4. Change in total cholesterol levels

    Time frame: Baseline to 9 months

    Assessment of total cholesterol levels using a portable biochemical analyzer.

  5. Change in handgrip strength

    Time frame: Baseline and 9 months

    Assessment of upper body isometric strength using a handgrip dynamometer. Measured in kilograms (kg)

  6. Change in lower body strength (countermovement jump height)

    Time frame: Baseline and 9 months

    Assessment of lower body strength using countermovement jump (CMJ) height measured with a contact platform (cm).

  7. Change in sprint performance

    Time frame: Baseline and 9 months

    Assessment of sprint performance using 10-30 meter sprint tests measured with photocell timing systems. Measured in seconds (s)

  8. Change in endurance capacity (Yo-Yo Intermittent Recovery Test Level 1)

    Time frame: Baseline and 9 months

    Assessment of endurance capacity using the Yo-Yo Intermittent Recovery Test Level 1, expressed as total distance covered (meters).

  9. Change in functional movement (Functional Movement Screen score)

    Time frame: 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.

  10. Change in joint range of motion

    Time frame: Baseline and 9 months

    Assessment of joint range of motion using goniometric measurements.

  11. Change in urine specific gravity

    Time frame: Baseline and 9 months

    Assessment of hydration status using urine specific gravity measured by refractometry.

  12. Change in hydration status (urine color scale)

    Time frame: 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.

  13. Change in blood pressure

    Time frame: Baseline and 9 months

    Measurement of systolic and diastolic blood pressure using a digital sphygmomanometer.

  14. Change in basal metabolic rate

    Time frame: Baseline and 9 months

    Assessment of basal metabolic rate using indirect calorimetry.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

Research and Development of New Sustainable Dietary and Nutritional Programs and Therapeutic Exercise for the Prevention of Metabolic and Musculoskeletal Disorders

Acronym: SUSTAINA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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