SportEffect of KA-ENCT07824752
Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players
A study testing KA-EX and Experimental: KA-EX Supplement in people with Sport and Muscle Fatigue, run by Antonio Molina Lopez at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport, Muscle Fatigue, Recovery of Function (G11.427.698.620)
- What is being tested?
- KA-EX and Experimental: KA-EX Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players: A Randomised, Double-Blind, Placebo-Controlled Study
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.
Read the detailed description
Background and Rationale: Post-exercise recovery is a critical determinant of performance and adaptation in high-level football players. Insufficient recovery can lead to decreased physical readiness and increased risk of injury. KA-EX is a nutritional supplement containing a complex of amino acids, electrolytes, and functional sugars designed to support metabolic and physiological recovery. This study aims to investigate its efficacy in a real-world elite training environment.
Study Objectives: The primary objective is to evaluate the effect of KA-EX supplementation on physiological recovery parameters (HRV). Secondary objectives include assessing the impact on sleep recovery indices, changes in body composition (via DEXA), and cellular health parameters (via BIA).
Methodology and Design: This is an experimental, randomized, double-blind, placebo-controlled study.
Participants: 25 male players from the Udine Primavera team (Italy). Intervention: Participants will be randomly assigned to an experimental group (KA-EX) or a control group (placebo). The products will be identical in appearance, taste, and packaging to ensure blinding.
Duration: The intervention will last for 2 months, typically following the pre-season period.
Procedures:
Baseline Assessment: Participants will undergo initial DEXA scans, bioelectrical impedance analysis (BIA 101), and anthropometric measurements. Monitoring with Garmin devices will be initiated.
Intervention Phase: Supplements or placebos will be administered immediately after every training session. Recovery variables (HRV and sleep) will be continuously monitored using Garmin algorithms.
Final Assessment: At the end of the 2-month period, DEXA, BIA, and anthropometric measurements will be repeated to evaluate longitudinal changes.
Statistical Analysis: Within-group and between-group differences will be analyzed to compare the magnitude of change from baseline to post-intervention. Temporal evolution of recovery metrics throughout the 8-week period will also be assessed.
- Conditions
- Sport, Muscle Fatigue, Recovery of Function (G11.427.698.620), Athletic Performance, Sleep Quality
- Being tested
- KA-EX, Experimental: KA-EX Supplement
- Keywords
- Heart Rate Variability, Soccer, Amino Acids, Body Composition, Garmin Wearables, DEXA, Post-Exercise Recovery
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KA-EXDietary 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.
Experimental: KA-EX SupplementDietary supplement
Powder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: KA-EX; Dietary Supplement: Experimental: KA-EX Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and daily for 8 weeks.
Secondary outcomes (3)
Change from Baseline in Sleep Score
Overall sleep quality score calculated by Garmin's proprietary algorithm based on sleep duration, REM, and deep sleep cycles.
Measured: Daily for 8 weeks.
Change from Baseline in Recovery Readiness Index
Daily readiness score (Body Battery) obtained via Garmin wearable algorithm. Scores range from 0 to 100; higher scores indicate greater physical readiness for training.
Measured: Daily for 8 weeks.
Body Composition
Body composition assessed at week 8. Lower values indicate reduction
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion5 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio Molina Lopez
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid, University of Udine, Universidad Pablo de Olavide
- Responsible party
- Sponsor-investigator, Antonio Molina Lopez, Universidad Pablo de Olavide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824752
- Sponsor's protocol ID
- UPO-KAEX-2026
- Acronym
- Effect of KA-E
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available for research purposes IPD Sharing Plan Description: "De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available for research purposes." Supporting Information: Selecciona: Study Protocol y Statistical Analysis Plan (SAP).
Publications
ClinicalTrials.gov. Individual Participant Data Sharing Plan Definitions. 2026.
International Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration Policy. 2024.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players: A Randomised, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07824752
- Acronym / sponsor ID
- Effect of KA-E / UPO-KAEX-2026
- Conditions
- Sport, Muscle Fatigue, Recovery of Function (G11.427.698.620), Athletic Performance, Sleep Quality
- Keywords
- Heart Rate Variability, Soccer, Amino Acids, Body Composition, Garmin Wearables, DEXA, Post-Exercise Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Antonio Molina LopezUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid, University of Udine, Universidad Pablo de Olavide
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale: Post-exercise recovery is a critical determinant of performance and adaptation in high-level football players. Insufficient recovery can lead to decreased physical readiness and increased risk of injury. KA-EX is a nutritional supplement containing a complex of amino acids, electrolytes, and functional sugars designed to support metabolic and physiological recovery. This study aims to investigate its efficacy in a real-world elite training environment.
Study Objectives: The primary objective is to evaluate the effect of KA-EX supplementation on physiological recovery parameters (HRV). Secondary objectives include assessing the impact on sleep recovery indices, changes in body composition (via DEXA), and cellular health parameters (via BIA).
Methodology and Design: This is an experimental, randomized, double-blind, placebo-controlled study.
Participants: 25 male players from the Udine Primavera team (Italy). Intervention: Participants will be randomly assigned to an experimental group (KA-EX) or a control group (placebo). The products will be identical in appearance, taste, and packaging to ensure blinding.
Duration: The intervention will last for 2 months, typically following the pre-season period.
Procedures:
Baseline Assessment: Participants will undergo initial DEXA scans, bioelectrical impedance analysis (BIA 101), and anthropometric measurements. Monitoring with Garmin devices will be initiated.
Intervention Phase: Supplements or placebos will be administered immediately after every training session. Recovery variables (HRV and sleep) will be continuously monitored using Garmin algorithms.
Final Assessment: At the end of the 2-month period, DEXA, BIA, and anthropometric measurements will be repeated to evaluate longitudinal changes.
Statistical Analysis: Within-group and between-group differences will be analyzed to compare the magnitude of change from baseline to post-intervention. Temporal evolution of recovery metrics throughout the 8-week period will also be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| KA-EX Group y Placebo Group. | Experimental | Dietary Supplement: KA-EX, Dietary Supplement: Experimental: KA-EX SupplementParticipants 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. |
| Placebo Group. | Placebo comparator | Dietary Supplement: KA-EX, Dietary Supplement: Experimental: KA-EX SupplementParticipants 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. |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KA-EXPowder sachet to be dissolved in water. Contains a patented complex of amino acids, electrolytes, and carbohydrates designed to normalize cortisol and support recovery. | Dietary supplement | KA-EX Group y Placebo Group., Placebo Group. |
| Experimental: KA-EX SupplementPowder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX. | Dietary supplement | KA-EX Group y Placebo Group., Placebo Group. |
Primary outcome
Change from Baseline in Heart Rate Variability (rMSSD)
Time frame: Baseline and daily for 8 weeks.
Autonomic recovery assessed as Root Mean Square of Successive Differences (rMSSD) during nocturnal sleep via Garmin wearable devices. Higher values indicate better parasympathetic recovery.
3 secondary outcomes
Change from Baseline in Sleep Score
Time frame: Daily for 8 weeks.
Change from Baseline in Recovery Readiness Index
Time frame: Daily for 8 weeks.
Body Composition
Time frame: 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Results publicationClinicalTrials.gov. Individual Participant Data Sharing Plan Definitions. 2026.
- Results publicationInternational Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration Policy. 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available for research purposes IPD Sharing Plan Description: "De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available for research purposes." Supporting Information: Selecciona: Study Protocol y Statistical Analysis Plan (SAP).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KA-EX and Experimental: KA-EX Supplement in people with Sport and Muscle Fatigue, run by Antonio Molina Lopez at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco J. Berral de la Rosa, PhD (+34672781737, nutrifarma@centrosnutrifarma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Heart Rate Variability (rMSSD) (time frame: Baseline and daily for 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07824752, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.