Effects of Tiger Milk Mushroom (Lignosus Rhinocerus) Supplementation on Physical Performance, Exercise Recovery, and Wellbeing in Physically Active Adults: A Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in Maximal Oxygen Uptake (VO₂max)
研究概览
简要总结
This study aims to evaluate the effects of Tiger Milk Mushroom (TMM) supplementation on physical performance and overall wellbeing in physically active adults.
Tiger Milk Mushroom (Lignosus rhinocerus) is a medicinal mushroom traditionally used in Southeast Asia for promoting health and vitality. Previous laboratory and clinical studies have suggested that Tiger Milk Mushroom possesses antioxidant, anti-inflammatory, and immunomodulatory properties that may support physical function, exercise recovery, and overall health.
In this randomized, double-blind, placebo-controlled trial, 60 physically active adults aged 18 years and above will be randomly assigned to receive either Tiger Milk Mushroom supplementation or a matching placebo for 12 weeks. Participants in the intervention group will consume one capsule of Tiger Milk Mushroom twice daily, while participants in the placebo group will consume matching placebo capsules following the same schedule. Assessments will be conducted at baseline, week 6, and week 12.
The study will evaluate physical performance through measurements of muscle strength, heart rate, self-paced walking performance, perceived exertion, and aerobic capacity (VO₂max). Blood samples will be collected to assess biomarkers related to cardiovascular endurance, exercise recovery, inflammation, and general health, including cortisol, total iron-binding capacity, creatine kinase, interleukin-2, and interleukin-6. Participants' stress levels and overall wellbeing will also be assessed using validated questionnaires.
The purpose of this study is to determine whether Tiger Milk Mushroom supplementation can support physical performance, exercise capacity, recovery, and overall wellbeing in physically active adults.
详细描述
Physical performance is an important determinant of overall health, functional capacity, and quality of life. Optimal physical performance depends on multiple physiological factors, including muscular strength, cardiovascular endurance, recovery capacity, and the regulation of inflammation and oxidative stress. During physical exertion, increased metabolic activity leads to the production of reactive oxygen species (ROS) and inflammatory mediators, which may contribute to muscle fatigue, impaired recovery, reduced exercise capacity, and decreased physical performance. Therefore, interventions capable of reducing oxidative stress and inflammation may offer benefits in enhancing physical performance and exercise recovery.
Lignosus rhinocerus, commonly known as Tiger Milk Mushroom (TMM), is a medicinal mushroom belonging to the Polyporaceae family and has been traditionally used in Southeast Asia and China for promoting general health and treating various ailments. The sclerotium of TMM contains numerous bioactive compounds, including polysaccharides, glycoproteins, phenolic compounds, and triterpenoids, which have been reported to possess antioxidant, anti-inflammatory, antimicrobial, immunomodulatory, and neuroprotective properties. Previous in vitro and animal studies have demonstrated that TMM can suppress the production of pro-inflammatory cytokines, including tumour necrosis factor-alpha (TNF-α), and protect cells against oxidative damage. These biological activities suggest a potential role for TMM in improving exercise performance and recovery.
Oxidative stress and exercise-induced inflammation are recognised contributors to muscle fatigue, reduced endurance, and impaired physical performance. Studies have shown that dietary interventions with antioxidant and anti-inflammatory properties may enhance muscle function, improve aerobic capacity, and accelerate post-exercise recovery. Given the documented antioxidant and anti-inflammatory activities of TMM, supplementation with TMM may help attenuate exercise-induced physiological stress, preserve muscle function, and enhance overall physical performance.
Although several studies have investigated the pharmacological properties of TMM and its effects on respiratory health, immunity, and antioxidant status, clinical evidence regarding its efficacy in improving physical performance remains limited. A previous randomized controlled trial reported beneficial effects of TMM supplementation combined with resistance training on muscular strength, aerobic fitness, anaerobic performance, and immune parameters in young adults. However, further studies are required to better understand the effects of TMM supplementation on physical performance, cardiovascular endurance, exercise recovery, inflammatory responses, and perceived wellbeing in healthy individuals.
Therefore, this study aims to evaluate the effects of Tiger Milk Mushroom supplementation on physical performance among healthy adults by assessing muscle strength, cardiovascular endurance, exercise-related inflammatory markers, stress levels, and overall wellbeing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors were blinded to treatment allocation throughout the study. Active and placebo capsules were identical in appearance, packaging, and administration schedule. Treatment allocation codes remained concealed until completion of data collection and statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults aged 18 years and above
- •Physically active individuals who regularly participate in physical exercise or fitness-related activities
- •Generally healthy based on self-reported medical history
- •Willing and able to comply with all study procedures and scheduled visits
- •Willing to provide written informed consent
排除标准
- •Current cigarette smokers
- •Users of psychoactive substances
- •Individuals consuming more than 600 mL of caffeinated beverages per day
- •Diagnosis of chronic metabolic diseases, including but not limited to type 2 diabetes mellitus or cardiovascular disease
- •Diagnosis of autoimmune disease
- •Pregnant or lactating women
- •Known allergy or hypersensitivity to mushroom-derived products
- •Current use of supplements or medications that may influence physical performance, inflammatory status, or immune function, as determined by the investigator
- •Participation in another clinical trial within 30 days prior to enrollment
- •Any medical condition that, in the opinion of the investigator, may interfere with study participation or interpretation of the study results
研究组 & 干预措施
Tiger Milk Mushroom (TMM)
Participants in this arm consumed Tiger Milk Mushroom (Lignosus rhinocerus) supplementation at a dosage of one capsule (300mg) twice daily for 12 weeks. Physical performance, cardiovascular endurance, inflammatory biomarkers, stress levels, and overall wellbeing were assessed at baseline, week 6, and week 12.
干预措施: Tiger Milk Mushroom (TMM) (Dietary Supplement)
Placebo
Participants in this arm consumed matching placebo capsules at a dosage of one capsule twice daily for 12 weeks. The placebo capsules were identical in appearance to the active supplement. Physical performance, cardiovascular endurance, inflammatory biomarkers, stress levels, and overall wellbeing were assessed at baseline, week 6, and week 12.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Maximal Oxygen Uptake (VO₂max)
时间窗: Baseline, Week 6, and Week 12
Change in estimated maximal oxygen uptake (VO₂max), an indicator of aerobic capacity and cardiovascular endurance. VO₂max was estimated using the Rockport One-Mile Walk Test based on walk completion time, post-exercise heart rate, age, sex, and body weight.
Change in Isometric Muscle Strength
时间窗: Baseline, Week 6, and Week 12
Muscle strength (kgf) of the elbow flexors, wrist extensors, shoulder abductors, hip flexors, knee extensors, and foot dorsiflexors was measured using a handheld muscle assessment dynamometer. Higher values indicate greater muscle strength (better outcome).
Change in Rating of Perceived Exertion (RPE)
时间窗: Baseline, Week 6, and Week 12
Rate of perceived exertion (RPE) was assessed using the Borg Category-Ratio 10 (CR10) Scale, with scores ranging from 0 to 10, where 0 indicates no exertion and 10 indicates maximal exertion. Lower scores indicate lower perceived exertion (better outcome), whereas higher scores indicate greater perceived exertion (worse outcome).
次要结局
- Change in Total Iron Binding Capacity (TIBC)(Baseline, and Week 12)
- Change in Serum Cortisol Levels(Baseline, Week 6, and Week 12)
- Change in Creatine Kinase Levels(Baseline, and Week 12)
- Changes in Lactate Levels(Baseline and week 12)
- Change in Inflammatory Levels(Baseline, and Week 12)
- Change in Perceived Stress Scale (PSS-10) Score(Baseline, Week 6, and Week 12)
- Change in Visual Analogue Scale (VAS) Score on Physical Fitness(Baseline, Week 6, and Week 12)
- Red Blood Cell Count(Baseline and Week 12)
- White Blood Cell Count(Baseline and Week 12)
- Platelet Count(Baseline and Week 12)
- Hepatic Function(Baseline and week 12)
- Blood Urea Nitrogen (BUN) Concentration(Baseline and week 12)
- Serum Creatinine Concentration(Baseline and week 12)
- Estimated Glomerular Filtration Rate (eGFR)(Baseline and week 12)