Effects of Nattokinase Supplementation on Strength Recovery and Muscle Damage Biomarkers Following Exercise-Induced Muscle Injury: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Peak Force During Isometric Mid-Thigh Pull (IMTP)
研究概览
简要总结
This pilot study aims to investigate whether 4 weeks of nattokinase supplementation (2,000 FU/day) affects recovery following exercise-induced muscle damage in healthy adult men. Approximately 12 to 16 participants aged 18 to 40 years will receive either nattokinase or a matching placebo during the supplementation period. After supplementation, participants will complete an exercise protocol designed to induce temporary muscle damage. Recovery will be evaluated using measures of muscle strength and exercise performance, muscle soreness, blood lactate, muscle oxygenation, and blood biomarkers related to muscle damage, inflammation, and oxidative stress. Measurements will be performed before and after the exercise-induced muscle damage protocol, including follow-up assessments during the recovery period. The study is intended to provide preliminary information on the potential effects of nattokinase supplementation on muscle recovery after strenuous exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged 18 to 40 years.
- •Regular exercise habits, defined as exercising at least 3 times per week, including at least 1 resistance-training session per week, with a stable exercise routine maintained during the previous 3 months.
- •No cardiovascular, metabolic, neurological, or musculoskeletal diseases that would prevent safe participation in the exercise testing, as assessed by the research team.
- •Not currently taking medications or dietary supplements that may affect blood coagulation.
- •No known allergy to natto or soy products.
排除标准
- •Current use of anticoagulant or antiplatelet medications.
- •History of bleeding disorders or abnormal blood coagulation.
- •Major surgery within the previous 3 months.
- •Known cardiovascular, renal, or other major chronic diseases.
- •History of severe lower-extremity musculoskeletal injury, such as fracture, ligament injury, or meniscal injury, when judged by the research team to make exercise testing inappropriate.
- •Current acute inflammation, infection, or another physical condition considered unsuitable for participation in exercise.
- •Participation in high-intensity or systematic plyometric training within the previous month.
- •Students currently supervised by the principal investigator or individuals with a relevant conflict of interest with the study.
研究组 & 干预措施
Placebo Group
Participants assigned to this arm will consume one matching placebo capsule daily for 28 days. The placebo is matched in appearance and flavor to the nattokinase supplement.
干预措施: Placebo (Dietary Supplement)
Nattokinase Group
Participants assigned to this arm will consume one capsule of nattokinase daily, providing 2,000 FU/day, for 28 days.
干预措施: Nattokinase (Dietary Supplement)
结局指标
主要结局
Peak Force During Isometric Mid-Thigh Pull (IMTP)
时间窗: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Peak force during the isometric mid-thigh pull (IMTP) will be measured to assess maximal isometric strength. The highest value from three trials will be used for analysis.
Countermovement Jump (CMJ) Height
时间窗: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Countermovement jump height will be measured to assess lower-limb explosive performance. The highest value from three trials will be used for analysis.
Blood Lactate Concentration
时间窗: During the Day 0, pre-EIMD, and immediately post-EIMD WAnT assessments; blood lactate will be measured before exercise, immediately after exercise, and at 3, 5, and 10 minutes post-exercise.
Blood lactate concentration will be measured before and after the Wingate Anaerobic Test (WAnT) to assess lactate production and clearance. The WAnT will be used as a standardized high-intensity exercise stimulus.
Muscle Oxygen Saturation (SmO₂)
时间窗: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Muscle oxygen saturation (SmO₂) will be measured using near-infrared spectroscopy (NIRS) to assess changes in muscle oxygenation.
Total Hemoglobin (THb)
时间窗: Day 0 baseline, pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD
Total hemoglobin (THb) will be measured using near-infrared spectroscopy (NIRS) to assess changes in local muscle blood volume.
Subjective Muscle Soreness Using Visual Analogue Scale (VAS)
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Subjective muscle soreness will be assessed using a 100-mm visual analogue scale (VAS), ranging from no soreness to worst possible soreness.
Subjective Muscle Soreness Using Borg CR-10 Scale
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Subjective muscle soreness will also be assessed using the Borg CR-10 scale, ranging from 0 to 10.
Pressure Pain Threshold (PPT)
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Pressure pain threshold (PPT) will be measured at the vastus lateralis using a pressure algometer to objectively assess muscle soreness.
Creatine Kinase (CK) Concentration
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood creatine kinase (CK) concentration will be measured as a marker of exercise-induced muscle damage.
Myoglobin Concentration
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood myoglobin concentration will be measured as a marker of exercise-induced muscle damage.
Lactate Dehydrogenase (LDH) Concentration
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood lactate dehydrogenase (LDH) concentration will be measured as a marker of exercise-induced muscle damage.
High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood high-sensitivity C-reactive protein (hs-CRP) concentration will be measured to assess the inflammatory response following EIMD.
Interleukin-6 (IL-6) Concentration
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood interleukin-6 (IL-6) concentration will be measured to assess the inflammatory response following EIMD.
Tumor Necrosis Factor-Alpha (TNF-α) Concentration
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood tumor necrosis factor-alpha (TNF-α) concentration will be measured to assess the inflammatory response following EIMD.
Malondialdehyde (MDA) Concentration
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Blood malondialdehyde (MDA) concentration will be measured as a marker of oxidative stress.
Total Antioxidant Capacity (TAC)
时间窗: Pre-EIMD baseline, immediately post-EIMD, 2 hours post-EIMD, 24 hours post-EIMD, and 48 hours post-EIMD.
Total antioxidant capacity (TAC) will be measured to assess antioxidant capacity following EIMD.
次要结局
- Body Fat Mass(Day 0 baseline and Day 28)
- Body Weight(Day 0 baseline and Day 28.)
- Body Mass Index (BMI)(Day 0 baseline and Day 28.)
- Skeletal Muscle Mass(Day 0 baseline and Day 28.)
- Skeletal Muscle Percentage(Day 0 baseline and Day 28.)
- Body Fat Percentage(Day 0 baseline and Day 28)
- Fat-Free Mass(Day 0 baseline and Day 28)
- Dietary Intake(Three-day dietary records at Day 0 and Day 28)
研究者
Yi-Ju Hsu
Professor
National Taiwan Sport University