Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players (Effect of KA-E)
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Francisco J. Berral de la Rosa, PhD
- 电话号码：+34672781737
- 邮箱：nutrifarma@centrosnutrifarma.es
学习地点
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Friuli Venecia
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Udine、Friuli Venecia、意大利、3310'
- Stadio BlueEnergy
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：KA-EX Group y Placebo Group.
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.
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Powder sachet to be dissolved in water.
Contains a patented complex of amino acids, electrolytes, and carbohydrates designed to normalize cortisol and support recovery.
Powder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX.
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安慰剂比较：Placebo Group.
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.
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Powder sachet to be dissolved in water.
Contains a patented complex of amino acids, electrolytes, and carbohydrates designed to normalize cortisol and support recovery.
Powder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in Heart Rate Variability (rMSSD)
大体时间：Baseline and daily for 8 weeks.
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Autonomic recovery assessed as Root Mean Square of Successive Differences (rMSSD) during nocturnal sleep via Garmin wearable devices.
Higher values indicate better parasympathetic recovery.
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Baseline and daily for 8 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in Sleep Score
大体时间：Daily for 8 weeks.
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Overall sleep quality score calculated by Garmin's proprietary algorithm based on sleep duration, REM, and deep sleep cycles.
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Daily for 8 weeks.
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Change from Baseline in Recovery Readiness Index
大体时间：Daily for 8 weeks.
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Daily readiness score (Body Battery) obtained via Garmin wearable algorithm.
Scores range from 0 to 100; higher scores indicate greater physical readiness for training.
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Daily for 8 weeks.
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Body Composition
大体时间：8 weeks.
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Body composition assessed at week 8. Lower values indicate reduction
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8 weeks.
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合作者和调查者
出版物和有用的链接
一般刊物
- ClinicalTrials.gov. Individual Participant Data Sharing Plan Definitions. 2026.
- International Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration Policy. 2024.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- UPO-KAEX-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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