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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Francisco J. Berral de la Rosa, PhD
- 電話番号：+34672781737
- メール：nutrifarma@centrosnutrifarma.es
研究場所
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Friuli Venecia
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Udine、Friuli Venecia、イタリア、3310'
- Stadio BlueEnergy
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参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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.
|
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.
|
|
プラセボコンパレーター：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Heart Rate Variability (rMSSD)
時間枠：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.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Sleep Score
時間枠：Daily for 8 weeks.
|
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
時間枠：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
時間枠：8 weeks.
|
Body composition assessed at week 8. Lower values indicate reduction
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8 weeks.
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協力者と研究者
協力者
協力者
出版物と役立つリンク
一般刊行物
- ClinicalTrials.gov. Individual Participant Data Sharing Plan Definitions. 2026.
- International Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration Policy. 2024.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- UPO-KAEX-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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