NCT07567066

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2026Sep 2026

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 20, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

NutritionExerciseMediterranean DietAthletesPrevention

Outcome Measures

Primary Outcomes (2)

  • Change in fat mass

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

    Baseline to 9 months

  • Change in lean body mass

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

    Baseline to 9 months

Secondary Outcomes (14)

  • Change in blood glucose levels

    Baseline to 9 months

  • Change in triglyceride levels

    Baseline to 9 months

  • Change in bone mineral content

    Baseline to 9 months

  • Change in total cholesterol levels

    Baseline to 9 months

  • Change in handgrip strength

    Baseline and 9 months

  • +9 more secondary outcomes

Study Arms (5)

Arm 1: Control Group

ACTIVE COMPARATOR

Nutritional intervention only (no structured exercise). Participants receive a personalized dietary intervention based on Mediterranean diet principles, without participation in a structured exercise program.

Behavioral: Behavioral: Nutritional Intervention

Arm 2: Traditional resistance training (hypertrophy) + nutritional intervention

EXPERIMENTAL

Participants perform a hypertrophy-focused resistance training program combined with a personalized dietary intervention.

Behavioral: Behavioral: Nutritional InterventionOther: Conventional Strength Training

Arm 3: Explosive strength training + nutritional intervention

EXPERIMENTAL

Participants perform an explosive strength training program combined with a personalized dietary intervention.

Behavioral: Behavioral: Nutritional InterventionOther: Explosive Strength Training

Arm 4: Functional training + nutritional intervention

EXPERIMENTAL

Participants perform a functional training program using alternative materials combined with a personalized dietary intervention.

Behavioral: Behavioral: Nutritional InterventionOther: Functional Training

Arm 5: Isoinertial training + nutritional intervention

EXPERIMENTAL

Participants perform an isoinertial resistance training program combined with a personalized dietary intervention.

Behavioral: Behavioral: Nutritional InterventionOther: Isoinertial Training

Interventions

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

Arm 1: Control GroupArm 2: Traditional resistance training (hypertrophy) + nutritional interventionArm 3: Explosive strength training + nutritional interventionArm 4: Functional training + nutritional interventionArm 5: Isoinertial training + nutritional intervention

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

Arm 2: Traditional resistance training (hypertrophy) + nutritional intervention

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

Arm 3: Explosive strength training + nutritional intervention

Exercise program based on functional movements using alternative training materials.

Arm 4: Functional training + nutritional intervention

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

Arm 5: Isoinertial training + nutritional intervention

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute Of Exercise and Health

Elche, Alicante, 03202, Spain

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Health Sciences

Study Record Dates

First Submitted

April 20, 2026

First Posted

May 5, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations