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

NCT06902662 | Completed

• 2 other identifiers: NTSUIRB-113-053NTSU No. 1141031
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Supplementation; Physical Performance

Keywords

muscle strength; anaerobic power; Sanghuangporus sanghuang; DEXA; testosterone

Outcome Measures

Primary Outcomes (2)

• Change 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).

  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.

  Baseline (Day 0) and Day 42

Secondary Outcomes (4)

• 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

Study Arms (2)

SS-MN4 Group

EXPERIMENTAL

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

Dietary Supplement: SS-MN4

Placebo Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

SS-MN4 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.

SS-MN4 Group

Placebo 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.

Placebo Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan Sport University: lead

Study Sites (1)

National Taiwan Sport University, Graduate Institute of Sports Science

Taoyuan District, 333325, Taiwan

Location

Related Publications (2)

• Lee MC, Hsu YJ, Ho CS, Chang CH, Liu CW, Huang CC, Chiang WD. Evaluation of the Efficacy of Supplementation with Planox(R) Lemon Verbena Extract in Improving Oxidative Stress and Muscle Damage: A Randomized Double-Blind Controlled Trial. Int J Med Sci. 2021 May 3;18(12):2641-2652. doi: 10.7150/ijms.60726. eCollection 2021.

  PMID: 34104096 RESULT

• 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.

  PMID: 31752370 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 30, 2025
• Study Start: April 7, 2025
• Primary Completion: July 15, 2025
• Study Completion: October 21, 2025
• Last Updated: April 13, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)