Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players

NCT07824752 | Not Yet Recruiting

• 1 other identifier: UPO-KAEX-2026
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of KA-EX supplementation on recovery parameters in elite young football players. Athletes from the Udine Primavera team will be randomly assigned to receive either the KA-EX supplement or a sensory-matched placebo immediately following their training sessions for a period of two months. The researchers will monitor heart rate variability (HRV) and sleep quality using Garmin wearable devices, and assess changes in body composition using Dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). The goal of the study is to determine if post-training KA-EX administration improves physiological recovery, sleep quality, and physical readiness in high-performance athletes during a competitive season.

Conditions

Sport; Athletic Performance; Sleep Quality; Recovery of Function (G11.427.698.620); Muscle Fatigue

Keywords

Heart Rate Variability; Soccer; Amino Acids; Body Composition; Garmin Wearables; DEXA; Post-Exercise Recovery

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Heart Rate Variability (rMSSD)

  Autonomic recovery assessed as Root Mean Square of Successive Differences (rMSSD) during nocturnal sleep via Garmin wearable devices. Higher values indicate better parasympathetic recovery.

  Baseline and daily for 8 weeks.

Secondary Outcomes (3)

• Change from Baseline in Sleep Score

  Daily for 8 weeks.

• Change from Baseline in Recovery Readiness Index

  Daily for 8 weeks.

• Body Composition

  8 weeks.

Study Arms (2)

KA-EX Group y Placebo Group.

EXPERIMENTAL

Participants in this arm will receive the KA-EX supplement immediately after each training session during the 2-month intervention period. KA-EX is a dietary supplement containing a complex of amino acids, electrolytes and functional sugars designed to support physiological recovery.

Dietary Supplement: KA-EX; Dietary Supplement: Experimental: KA-EX Supplement

Placebo Group.

PLACEBO COMPARATOR

Participants in this arm will receive a placebo supplement immediately after each training session during the 2-month intervention period. The placebo is organoleptically identical to the experimental supplement in terms of appearance, taste, texture and packaging to ensure double-blinding.

Dietary Supplement: KA-EX; Dietary Supplement: Experimental: KA-EX Supplement

Interventions

KA-EX DIETARY_SUPPLEMENT

Powder sachet to be dissolved in water. Contains a patented complex of amino acids, electrolytes, and carbohydrates designed to normalize cortisol and support recovery.

KA-EX Group y Placebo Group.; Placebo Group.

Experimental: KA-EX Supplement DIETARY_SUPPLEMENT

Powder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX.

KA-EX Group y Placebo Group.; Placebo Group.

Eligibility Criteria

• Age: 17 Years - 20 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Membership of the Udine Primavera team at the time of the study. Regular participation in the training programme during the intervention period (September).
• Provision of written informed consent to participate in the study. Willingness to use a Garmin wearable device for continuous monitoring of recovery variables.

You may not qualify if:

• Presence of any injury or medical condition that limits normal participation in team training sessions.
• Use of any other recovery supplements or ergogenic aids outside of the study protocol during the intervention period.
• Failure to comply with the daily supplementation protocol or the scheduled assessment sessions (DEXA/BIA).

Sponsors & Collaborators

• Antonio Molina Lopez: lead
• Universidad Europea de Madrid: collaborator
• University of Udine: collaborator
• Universidad Pablo de Olavide: collaborator

Study Sites (1)

Stadio BlueEnergy

Udine, Friuli Venecia, 3310', Italy

Location

Related Publications (2)

• ClinicalTrials.gov. Individual Participant Data Sharing Plan Definitions. 2026.

  RESULT

• International Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration Policy. 2024.

  RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Francisco J. Berral de la Rosa, PhD

CONTACT

+34672781737; nutrifarma@centrosnutrifarma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both KA-EX and Placebo are provided in sensory-matched packaging (same taste, texture, and appearance) to ensure neither the athletes nor the researchers collecting Garmin and BIA data know the allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Profesor

Model Details: Participants are randomly assigned to one of two groups (KA-EX or Placebo) for the entire 2-month duration of the intervention to compare between-group differences in recovery parameters.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 17, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: "Data will be available beginning 6 months and ending 36 months following article publication."
• Access Criteria: "Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to the corresponding author."

Locations

IT (1)