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临床试验/NCT07726979
NCT07726979已完成不适用

An Exploration of the Combined Effects of Cordyceps Supplementation and Fartlek Training on Inflammatory, Oxidative Stress, Muscle Damage, and Bone Metabolism Biomarkers (IL-6, IL-10, SOD, MDA, CK, BaLP, OST) in Soccer Players

Surabaya State University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Change from Baseline in Serum Creatine Kinase (CK) Concentration After 4 Weeks

研究概览

简要总结

Purpose of the Study:This study aims to evaluate the effectiveness of combining Cordyceps supplementation and fartlek training as a recovery and performance enhancement strategy for soccer players. Muscle injuries often occur when athletes train intensely without adequate recovery. Cordyceps contains bioactive compounds with anti-inflammatory and antioxidant properties, while Fartlek training is designed to improve cardiovascular endurance. This study analyses how this combination affects both the physiological recovery and physical performance of soccer players. Research Question: Does the combination of Cordyceps supplementation and Fartlek training effectively reduce muscle damage, decrease oxidative stress, promote bone metabolism, and improve cardiorespiratory fitness in soccer players? Methodology and Biomarkers: To answer this question, the study evaluates specific physiological indicators from the participants' blood samples and physical tests. Muscle damage and recovery are assessed through creatine kinase (CK), interleukin-6 (IL-6), and interleukin-10 (IL-10). Oxidative stress levels are monitored using superoxide dismutase (SOD) and malondialdehyde (MDA). Bone metabolism and health are measured via bone alkaline phosphatase (BALP) and osteocalcin (OST). Additionally, improvements in the athletes' aerobic capacity and overall physical performance are determined by measuring their maximal oxygen consumption (VO₂max).

详细描述

High-intensity athletic training, such as soccer, places rigorous physiological stress on the human body, frequently leading to exercise-induced muscle damage (EIMD), systemic inflammation, and elevated oxidative stress. When recovery periods are insufficient, these factors culminate in persistent fatigue, compromised bone metabolism, and an increased risk of injury. This study investigates a novel, multifaceted recovery and conditioning paradigm by combining the adaptogenic properties of Cordyceps supplementation with the cardiovascular demands of Fartlek training. Mechanistic Framework of Cordyceps and Fartlek TrainingCordyceps contains potent bioactive compounds, including cordycepin, polysaccharides, adenosine, and mannitol. These constituents exhibit strong anti-inflammatory, antioxidant, and anti-apoptotic properties at the cellular level. By counteracting the excessive accumulation of free radicals and downregulating pro-inflammatory pathways (such as NF-$\kappa$B activation), Cordyceps is hypothesised to accelerate structural muscle repair. Concurrently, Fartlek training-a form of continuous training with alternating bursts of high and low intensity-acts as a potent stimulus for cardiovascular and aerobic conditioning, driving adaptations in capillary density and mitochondrial efficiency. Physiological and Biomarker Profiles This trial utilises a comprehensive panel of serum and physical biomarkers to map the synergistic effects of the intervention: Inflammatory Response & Muscle Damage: The study monitors the kinetics of interleukins to evaluate the shift from a pro-inflammatory state to an anti-inflammatory recovery environment. Interleukin-6 (IL-6) serves as a marker of acute metabolic and inflammatory stress, while interleukin-10 (IL-10) is analysed to track the activation of anti-inflammatory signalling. Additionally, Creatine Kinase (CK) levels are measured as a direct indicator of sarcolemmal disruption and micro-tears in muscle fibres. Oxidative Stress Regulation: To evaluate the antioxidant capacity, the trial quantifies Malondialdehyde (MDA), a primary byproduct of lipid peroxidation, against the activity of Superoxide Dismutase (SOD), an essential endogenous antioxidant enzyme responsible for neutralising superoxide radicals. Bone Metabolism and Turnover: High-impact sports alter bone remodelling. This study assesses the skeletal response to the combined protocol by tracking Bone Alkaline Phosphatase (BALP), a specific marker of osteoblastic bone formation, and Osteocalcin (OST), a non-collagenous protein essential for bone matrix mineralisation and metabolic regulation. Aerobic Power and Adaptation: Beyond biochemical markers, the ultimate physiological translation of enhanced recovery is measured via maximal oxygen consumption (VO₂max). This metric serves to evaluate whether the accelerated recovery mediated by Cordyceps allows athletes to achieve superior cardiorespiratory adaptations during Fartlek conditioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

In addition to the participants and outcome assessors, the biostatistician responsible for the final statistical data analysis was also kept completely anonymous in this trial. All datasets were provided to data analysts using pre-coded group labels (Fartlek cordyceps and Fartlek Placebo) instead of the actual intervention names. The independent researcher who generated the randomization allocation securely holds the master code, and it will not be leaked or disclosed to data analysts until all statistical calculations and interpretation of conclusions are formally completed.

入排标准

年龄范围
18 Years 至 20 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Kriteria Inklusi:
  • Status saat ini sebagai atlet sepak bola kompetitif aktif.
  • Berusia antara 18 dan 20 tahun.
  • Memiliki asupan oksigen maksimal (VO2max) dasar minimal 44 mL·kg-¹·min-¹.
  • Dinyatakan sehat secara fisik dan mental berdasarkan pemeriksaan medis.
  • Bersedia mematuhi protokol pelatihan Fartlek dan jadwal suplementasi kapsul yang telah ditentukan.
  • Memberikan persetujuan tertulis untuk berpartisipasi dalam penelitian.
  • Kriteria Eksklusi:
  • Berusia di bawah 18 tahun.
  • Terdaftar aktif di klub profesional pada saat penelitian.
  • Riwayat cedera muskuloskeletal atau fisik yang mengganggu performa pelatihan maksimal.
  • Saat ini mengonsumsi suplemen makanan, alat bantu ergogenik, atau obat-obatan lain dalam 4 minggu sebelum pengukuran awal.
  • Memiliki alergi atau hipersensitivitas terhadap Cordyceps sinensis atau komponen kapsul apa pun.

排除标准

  • 未提供

结局指标

主要结局

Change from Baseline in Serum Creatine Kinase (CK) Concentration After 4 Weeks

时间窗: Baseline and Post-Intervention (Week 4)

Serum Creatine Kinase (CK) is measured to evaluate the extent of exercise-induced muscle damage. Blood samples are analyzed using an automated biochemistry analyzer. An increase in CK levels indicates muscle fiber disruption, while lower post-exercise levels in the intervention group suggest a protective effect of the supplement. Results are reported in Units per Liter (U/L)

Change from Baseline in Serum Interleukin-6 (IL-6) Levels After 4 Weeks

时间窗: Baseline and Post-Intervention (Week 4)

Serum Interleukin-6 (IL-6) is measured as a primary biomarker for acute systemic inflammatory responses and muscle-derived cytokine secretion induced by high-intensity training. Blood samples are analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Lower change scores indicate suppressed systemic pro-inflammatory pathways. Results are reported in picograms per milliliter (pg/mL)

Change from Baseline in Serum Interleukin-10 (IL-10) Levels After 4 Weeks

时间窗: Baseline and Post-Intervention (Week 4)

Serum Interleukin-10 (IL-10) is measured to evaluate the anti-inflammatory response to exercise stress. Blood samples are analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique. Higher change scores or maintained levels of this cytokine indicate a well-regulated anti-inflammatory mechanism that assists in tissue repair and resolution of inflammation. Results are reported in picograms per milliliter (pg/mL).

Change from Baseline in Superoxide Dismutase (SOD) Activity After 4 Weeks

时间窗: Baseline and Post-Intervention (Week 4)

Superoxide Dismutase (SOD) activity is measured to assess endogenous antioxidant enzyme defenses against oxidative stress induced by strenuous exercise. Blood samples are analyzed using a spectrophotometric assay kit. Higher change scores indicate enhanced antioxidant capacity to neutralize reactive oxygen species (ROS). Results are reported in Units per milliliter (U/mL).

Change from Baseline in Serum Malondialdehyde (MDA) Levels After 4 Weeks

时间窗: Baseline and Post-Intervention (Week 4)

Serum Malondialdehyde (MDA) is measured as a key biomarker of lipid peroxidation to quantify oxidative damage to cell membranes resulting from high-intensity training. Blood samples are analyzed using the Thiobarbituric Acid Reactive Substances (TBARS) spectrophotometric assay. Lower change scores signify mitigated oxidative stress and cellular protection. Results are reported in nanomoles per milliliter (nmol/mL)

Change from Baseline in Maximal Oxygen Uptake (VO2max) After 4 Weeks of Training

时间窗: Baseline and Post-Intervention (Week 4)

Maximal oxygen uptake (VO2max) is measured to evaluate improvements in cardiorespiratory fitness and aerobic capacity. Participants undergo a standardized physical fitness field test (such as the Yo-Yo Intermittent Recovery Test or a progressive shuttle run test) specific to soccer players. Higher change scores indicate superior aerobic adaptation and physiological conditioning. Results are reported in milliliters of oxygen per kilogram of body weight per minute (mL/kg/min).

次要结局

  • Change from Baseline in Bone Alkaline Phosphatase (BALP) Levels After 4 Weeks(Baseline and Post-Intervention (Week 4))
  • Change from Baseline in Serum Osteocalcin (OST) Concentration After 4 Weeks(Baseline and Post-Intervention (Week 4))

研究者

发起方
Surabaya State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bayu Agung Pramono

Graduate Student and Principal Investigator

Surabaya State University

研究点 (1)

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