Clinical trial NCT06902662: Sanghuangporus Sanghuang Supplementation to Improve Anti-Fatigue Performance in Healthy Adults
Official title: Clinical Evaluation of Sanghuangporus Sanghuang in Anti-fatigue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutritional Supplementation
Physical Performance
Keywords: muscle strength
anaerobic power
Sanghuangporus sanghuang
DEXA
testosterone
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-arm randomized, double-blind, parallel-group controlled trial comparing SS-MN4 supplementation versus placebo over 42 days.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Serum Creatine Kinase (CK) Level
timeFrame: Baseline (Day 0), Day 21, Day 42, and 3/24/48 hours after exhaustive exercise
measure: Change in Isometric Mid-Thigh Pull (IMTP) Strength
timeFrame: Baseline (Day 0) and Day 42
Secondary outcomes:
measure: Change in Serum Cortisol and Testosterone Levels
timeFrame: Baseline (Day 0), Day 21, Day 42, and 3/24/48 hours post-exercise
measure: Change in Fat-Free Mass Measured by DEXA
timeFrame: Baseline (Day 0) and Day 42
measure: Change in Anaerobic Power (Wingate Test)
timeFrame: Baseline (Day 0) and Day 42
measure: Change in 3-Methylhistidine/Creatinine Ratio in Urine
timeFrame: 24 hours post-exhaustive exercise
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: National Taiwan Sport University, Graduate Institute of Sports Science
Study officials:
References:
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citation: Huang WC, Lee MC, Lee CC, Ng KS, Hsu YJ, Tsai TY, Young SL, Lin JS, Huang CC. Effect of Lactobacillus plantarum TWK10 on Exercise Physiological Adaptation, Performance, and Body Composition in Healthy Humans. Nutrients. 2019 Nov 19;11(11):2836. doi: 10.3390/nu11112836.