Clinical Evaluation of Sanghuangporus Sanghuang in Anti-fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in Serum Creatine Kinase (CK) Level
研究概览
简要总结
This clinical study aims to evaluate the anti-fatigue and muscle performance-enhancing effects of Sanghuangporus sanghuang mycelia (SS-MN4) capsules in healthy adults. As muscle mass and function naturally decline with age or sedentary lifestyle, there is growing interest in nutritional interventions that may help preserve physical performance and reduce fatigue. Sanghuangporus sanghuang, a traditional medicinal fungus, contains bioactive compounds such as hispidin, known for their antioxidant and anti-inflammatory properties.
The study is a randomized, double-blind, placebo-controlled trial involving 60 healthy male participants aged 20 to 35 years with no regular exercise habits. Participants will be randomly assigned to receive either SS-MN4 capsules (1000 mg/day) or a placebo for 42 days. The intervention aims to determine whether SS-MN4 improves exercise performance, muscle strength, and biochemical markers related to fatigue and muscle damage.
Throughout the study, blood samples, urine samples, exercise tests (e.g., anaerobic power, isometric strength), and body composition analyses (DEXA) will be conducted at multiple time points, including before, during, and after the intervention. In addition, intestinal microbiota analysis and nutritional intake records will be included to assess secondary outcomes.
This research will provide scientific evidence for the health benefits of SS-MN4 in reducing exercise-induced fatigue and improving muscle function. The data collected may support future applications for anti-fatigue health food certification in Taiwan and the development of novel functional supplements for global markets.
详细描述
This study is designed to investigate the efficacy of Sanghuangporus sanghuang mycelia (SS-MN4) capsules in improving anti-fatigue capacity and muscle performance in healthy adult males without regular exercise habits. The clinical trial is based on preclinical studies showing that hispidin-rich SS-MN4 extracts exert protective effects on muscle cells exposed to dexamethasone-induced damage, suggesting potential benefits for preventing muscle fatigue and atrophy.
With muscle mass and strength declining steadily after age 30, sedentary lifestyles can further accelerate sarcopenia, metabolic dysfunction, and poor physical performance. The development of effective functional ingredients to combat fatigue and muscle deterioration is crucial in modern health promotion, especially in aging populations. Sanghuangporus sanghuang is a traditional medicinal fungus with demonstrated antioxidant, anti-inflammatory, and anti-fatigue properties, making it a promising candidate for functional supplementation.
This is a randomized, double-blind, two-arm, placebo-controlled trial. A total of 60 healthy male participants aged 20 to 35 years will be recruited. They will be randomly assigned to one of two groups: the intervention group will receive two SS-MN4 capsules daily (1000 mg/day), and the placebo group will receive identical capsules with inert content. The intervention period will last 42 days, followed by a 4-week follow-up.
Primary outcome measures include changes in biochemical fatigue markers such as creatine kinase (CK), high-sensitivity C-reactive protein (hs-CRP), cortisol, and testosterone. Muscle function and physical performance will be evaluated through anaerobic power testing, isometric mid-thigh pull (IMTP), vertical jump testing, and endurance tests. Blood and urine samples will be collected at multiple time points (pre-intervention, mid-intervention, post-intervention, and during recovery after exhaustive exercise). Muscle damage indicators (e.g., MDA, myoglobin, 3-methylhistidine/creatinine ratio) will also be assessed.
Secondary outcomes include body composition (measured via DEXA), nutritional intake analysis (via the Cofit app and professional nutritionist review), and gut microbiota profiling using 16S rRNA sequencing. All assessments will be conducted in compliance with Taiwan's Ministry of Health and Welfare anti-fatigue health food evaluation guidelines, and supervised by qualified professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The study is a double-blind randomized controlled trial. Both participants and investigators are blinded to group assignments. The SS-MN4 and placebo capsules are identical in appearance, taste, and packaging. Randomization and labeling were managed by an independent third party not involved in the study execution.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male participants aged between 20 and 35 years
- •Non-smokers and non-drinkers
- •Not currently taking any dietary supplements or medications
- •Normal liver and kidney function
- •No chronic diseases such as cardiovascular disease
- •Willing and able to provide written informed consent
- •Able to comply with study procedures and schedule
排除标准
- •Current or past diagnosis of any cardiovascular, liver, kidney, or metabolic disease
- •Regular use of dietary supplements, sports nutrition products, or energy drinks
- •Known food allergies or intolerances, particularly to mushrooms or herbal products
- •Engaging in regular resistance or endurance training in the last 6 months
- •Currently taking medications that may interfere with study outcomes
- •Smoking or alcohol consumption
- •Participation in other clinical trials within the last 3 months
研究组 & 干预措施
SS-MN4 Group
Participants will take 2 capsules of Sanghuangporus sanghuang mycelia (SS-MN4) daily (1000 mg/day) for 42 days.
干预措施: SS-MN4 (Dietary Supplement)
Placebo Group
Participants will take 2 capsules daily of a placebo identical in appearance and taste to the SS-MN4 supplement for 42 days.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Serum Creatine Kinase (CK) Level
时间窗: Baseline (Day 0), Day 21, Day 42, and 3/24/48 hours after exhaustive exercise
Serum CK will be measured to assess muscle damage related to exercise fatigue using automatic biochemical analyzers (Hitachi 7060).
Change in Isometric Mid-Thigh Pull (IMTP) Strength
时间窗: Baseline (Day 0) and Day 42
Isometric muscle strength will be evaluated using IMTP racks and force plates (Kistler) to measure maximal force and rate of force development.
次要结局
- Change in Serum Cortisol and Testosterone Levels(Baseline (Day 0), Day 21, Day 42, and 3/24/48 hours post-exercise)
- Change in Fat-Free Mass Measured by DEXA(Baseline (Day 0) and Day 42)
- Change in Anaerobic Power (Wingate Test)(Baseline (Day 0) and Day 42)
- Change in 3-Methylhistidine/Creatinine Ratio in Urine(24 hours post-exhaustive exercise)
研究者
Chi-Chang Huang
Professor
National Taiwan Sport University