Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players: A Randomised, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change from Baseline in Heart Rate Variability (rMSSD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 17 Years 至 20 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: KA-EX (Dietary Supplement)
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.
干预措施: Experimental: KA-EX Supplement (Dietary Supplement)
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.
干预措施: KA-EX (Dietary Supplement)
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.
干预措施: Experimental: KA-EX Supplement (Dietary Supplement)
结局指标
主要结局
Change from Baseline in Heart Rate Variability (rMSSD)
时间窗: 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.
次要结局
- 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.)
研究者
Antonio Molina Lopez
Profesor
Universidad Pablo de Olavide