Nutritional SupplementationSSMN4-AFNCT06902662
Sanghuangporus Sanghuang Supplementation to Improve Anti-Fatigue Performance in Healthy Adults
A study testing SS-MN4 in people with Nutritional Supplementation and Physical Performance, run by National Taiwan Sport University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional Supplementation, Physical Performance
- What is being tested?
- SS-MN4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2025to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan Sport University, Graduate Institute of Sports Science
Taoyuan, 333325
About this study
Official title: Clinical Evaluation of Sanghuangporus Sanghuang in Anti-fatigue
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.
Read more
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.
Read the 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.
- Conditions
- Nutritional Supplementation, Physical Performance
- Being tested
- SS-MN4, Placebo
- Keywords
- muscle strength, anaerobic power, Sanghuangporus sanghuang, DEXA, testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SS-MN4Dietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| SS-MN4 Group | Experimental | Participants will take 2 capsules of Sanghuangporus sanghuang mycelia (SS-MN4) daily (1000 mg/day) for 42 days. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline (Day 0) and Day 42
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours post-exhaustive exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start7 Apr 2025
- Primary completion15 Jul 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutritional SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 2-arm randomized, double-blind, parallel-group controlled trial comparing SS-MN4 supplementation versus placebo over 42 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Chang Huang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902662
- Sponsor's protocol ID
- NTSUIRB-113-053
- Other IDs
- NTSU No. 1141031
- Acronym
- SSMN4-AF
- Status last verified
- May 2025
- First submitted
- 22 Mar 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves a small sample size and is limited to a specific academic-industry collaboration. Data sharing is not included in the original informed consent and ethical approval.
Publications
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.
PubMed 34104096Huang 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.
PubMed 31752370
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Sanghuangporus Sanghuang in Anti-fatigue
- ClinicalTrials.gov ID
- NCT06902662
- Acronym / sponsor ID
- SSMN4-AF / NTSUIRB-113-053
- Conditions
- Nutritional Supplementation, Physical Performance
- Keywords
- muscle strength, anaerobic power, Sanghuangporus sanghuang, DEXA, testosterone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A 2-arm randomized, double-blind, parallel-group controlled trial comparing SS-MN4 supplementation versus placebo over 42 days.
| Arm | Type | Receives |
|---|---|---|
| SS-MN4 Group | Experimental | Dietary Supplement: SS-MN4Participants will take 2 capsules of Sanghuangporus sanghuang mycelia (SS-MN4) daily (1000 mg/day) for 42 days. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants will take 2 capsules daily of a placebo identical in appearance and taste to the SS-MN4 supplement for 42 days. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SS-MN4Participants 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. | Dietary supplement | SS-MN4 Group |
| PlaceboParticipants 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. | Dietary supplement | Placebo Group |
Primary outcome
Change in Serum Creatine Kinase (CK) Level
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change in Serum Cortisol and Testosterone Levels
Time frame: Baseline (Day 0), Day 21, Day 42, and 3/24/48 hours post-exercise
Change in Fat-Free Mass Measured by DEXA
Time frame: Baseline (Day 0) and Day 42
Change in Anaerobic Power (Wingate Test)
Time frame: Baseline (Day 0) and Day 42
Change in 3-Methylhistidine/Creatinine Ratio in Urine
Time frame: 24 hours post-exhaustive exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Results publication: PubMed 34104096Lee 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.
- Results publication: PubMed 31752370Huang 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves a small sample size and is limited to a specific academic-industry collaboration. Data sharing is not included in the original informed consent and ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SS-MN4 in people with Nutritional Supplementation and Physical Performance, run by National Taiwan Sport University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Creatine Kinase (CK) Level (time frame: Baseline (Day 0), Day 21, Day 42, and 3/24/48 hours after exhaustive exercise). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06902662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.