Sanghuangporus Sanghuang Supplementation to Improve Anti-Fatigue Performance in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2025-10-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Nutritional Supplements in Treatment of Elderly Mild-to-Moderate COVID-19

NCT05629975

Nutrition, Healthy

UNKNOWN NA

Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity

NCT04664361

Physical Activity Muscle Recovery

COMPLETED NA

Effects of Coenzyme Q10 Supplementation on Oxidative Stress, Antioxidant Capacity, Inflammatory Responses, Fatigue Elimination, and Exercise Performance in Athletes

NCT03321110

Athlete

COMPLETED NA

The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue

NCT05877677

Fatigue

COMPLETED NA

The Effects of Chicken Extract on Mental Energy in Healthy Adults and the Underlying Mechanisms

NCT06021223

Healthy Adults

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nutritional Supplementation Physical Performance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 2-arm randomized, double-blind, parallel-group controlled trial comparing SS-MN4 supplementation versus placebo over 42 days.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SS-MN4 Group

Participants will take 2 capsules of Sanghuangporus sanghuang mycelia (SS-MN4) daily (1000 mg/day) for 42 days.

Group Type EXPERIMENTAL

SS-MN4

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo Group

Participants will take 2 capsules daily of a placebo identical in appearance and taste to the SS-MN4 supplement for 42 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SS-MN4

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes