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.
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. The results will provide clinical evidence supporting SS-MN4 as a novel functional ingredient for enhancing exercise performance and reducing fatigue. Findings will be used for potential health food certification applications and for supporting international marketing of SS-MN4 as a scientifically validated supplement.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Participants in the SS-MN4 group will take 2 capsules daily containing a total of 1000 mg/day of Sanghuangporus sanghuang mycelia extract for 42 consecutive days. The capsules are identical in appearance to the placebo.
Participants in the placebo group will take 2 capsules daily of an inert substance designed to match the SS-MN4 capsules in color, taste, and appearance. The placebo contains no active ingredients and will be taken for 42 consecutive days.
National Taiwan Sport University, Graduate Institute of Sports Science
Taoyuan District, Taiwan
RECRUITINGChange in Serum Creatine Kinase (CK) Level
Serum CK will be measured to assess muscle damage related to exercise fatigue using automatic biochemical analyzers (Hitachi 7060).
Time frame: Baseline (Day 0), Day 21, Day 42, and 3/24/48 hours after exhaustive exercise
Change in Isometric Mid-Thigh Pull (IMTP) Strength
Isometric muscle strength will be evaluated using IMTP racks and force plates (Kistler) to measure maximal force and rate of force development.
Time frame: Baseline (Day 0) and Day 42
Change in Serum Cortisol and Testosterone Levels
Serum cortisol and testosterone will be measured by ELISA to evaluate physiological stress and hormone response to supplementation and exercise.
Time frame: Baseline (Day 0), Day 21, Day 42, and 3/24/48 hours post-exercise
Change in Fat-Free Mass Measured by DEXA
Body composition will be assessed using dual-energy X-ray absorptiometry (DEXA; Lunar iDXA) to evaluate changes in muscle mass.
Time frame: Baseline (Day 0) and Day 42
Change in Anaerobic Power (Wingate Test)
Anaerobic performance will be measured using a cycle ergometer protocol, assessing peak power, mean power, and fatigue index.
Time frame: Baseline (Day 0) and Day 42
Change in 3-Methylhistidine/Creatinine Ratio in Urine
The ratio of 3-Methylhistidine to creatinine in urine will be analyzed to evaluate muscle protein breakdown.
Time frame: 24 hours post-exhaustive exercise
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