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Physical PerformancesNCT07756788

Effects of Tiger Milk Mushroom Supplementation on Physical Performance in Physically Active Adults

A study testing Tiger Milk Mushroom (TMM) in people with Physical Performances and Physical Fitness, run by Nexus Wise Sdn Bhd at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the effects of Tiger Milk Mushroom (TMM) supplementation on physical performance and overall wellbeing in physically active adults. Tiger Milk Mushroom (Lignosus rhinocerus) is a medicinal mushroom traditionally used in Southeast Asia for promoting health and vitality. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Tiger Milk Mushroom (TMM)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteMalaysia
Study dates
1 Jan 2025to 31 May 2026
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female adults aged 18 years and above
  • Physically active individuals who regularly participate in physical exercise or fitness-related activities
  • Generally healthy based on self-reported medical history
  • Willing and able to comply with all study procedures and scheduled visits
  • Willing to provide written informed consent

Who cannot join

  • Current cigarette smokers
  • Users of psychoactive substances
  • Individuals consuming more than 600 mL of caffeinated beverages per day
  • Diagnosis of chronic metabolic diseases, including but not limited to type 2 diabetes mellitus or cardiovascular disease
  • Diagnosis of autoimmune disease
  • Pregnant or lactating women
Show all 10Show fewer
  • Known allergy or hypersensitivity to mushroom-derived products
  • Current use of supplements or medications that may influence physical performance, inflammatory status, or immune function, as determined by the investigator
  • Participation in another clinical trial within 30 days prior to enrollment
  • Any medical condition that, in the opinion of the investigator, may interfere with study participation or interpretation of the study results

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • UCSI University

    Cheras, Kuala Lumpur, 56000

Other trials in Malaysia

About this study

Official title: Effects of Tiger Milk Mushroom (Lignosus Rhinocerus) Supplementation on Physical Performance, Exercise Recovery, and Wellbeing in Physically Active Adults: A Randomized Double-Blind Placebo-Controlled Trial

This study aims to evaluate the effects of Tiger Milk Mushroom (TMM) supplementation on physical performance and overall wellbeing in physically active adults.

Tiger Milk Mushroom (Lignosus rhinocerus) is a medicinal mushroom traditionally used in Southeast Asia for promoting health and vitality. Previous laboratory and clinical studies have suggested that Tiger Milk Mushroom possesses antioxidant, anti-inflammatory, and immunomodulatory properties that may support physical function, exercise recovery, and overall health.

Read more

In this randomized, double-blind, placebo-controlled trial, 60 physically active adults aged 18 years and above will be randomly assigned to receive either Tiger Milk Mushroom supplementation or a matching placebo for 12 weeks. Participants in the intervention group will consume one capsule of Tiger Milk Mushroom twice daily, while participants in the placebo group will consume matching placebo capsules following the same schedule. Assessments will be conducted at baseline, week 6, and week 12.

The study will evaluate physical performance through measurements of muscle strength, heart rate, self-paced walking performance, perceived exertion, and aerobic capacity (VO₂max). Blood samples will be collected to assess biomarkers related to cardiovascular endurance, exercise recovery, inflammation, and general health, including cortisol, total iron-binding capacity, creatine kinase, interleukin-2, and interleukin-6. Participants' stress levels and overall wellbeing will also be assessed using validated questionnaires.

The purpose of this study is to determine whether Tiger Milk Mushroom supplementation can support physical performance, exercise capacity, recovery, and overall wellbeing in physically active adults.

Read the detailed description

Physical performance is an important determinant of overall health, functional capacity, and quality of life. Optimal physical performance depends on multiple physiological factors, including muscular strength, cardiovascular endurance, recovery capacity, and the regulation of inflammation and oxidative stress. During physical exertion, increased metabolic activity leads to the production of reactive oxygen species (ROS) and inflammatory mediators, which may contribute to muscle fatigue, impaired recovery, reduced exercise capacity, and decreased physical performance. Therefore, interventions capable of reducing oxidative stress and inflammation may offer benefits in enhancing physical performance and exercise recovery.

Lignosus rhinocerus, commonly known as Tiger Milk Mushroom (TMM), is a medicinal mushroom belonging to the Polyporaceae family and has been traditionally used in Southeast Asia and China for promoting general health and treating various ailments. The sclerotium of TMM contains numerous bioactive compounds, including polysaccharides, glycoproteins, phenolic compounds, and triterpenoids, which have been reported to possess antioxidant, anti-inflammatory, antimicrobial, immunomodulatory, and neuroprotective properties. Previous in vitro and animal studies have demonstrated that TMM can suppress the production of pro-inflammatory cytokines, including tumour necrosis factor-alpha (TNF-α), and protect cells against oxidative damage. These biological activities suggest a potential role for TMM in improving exercise performance and recovery.

Oxidative stress and exercise-induced inflammation are recognised contributors to muscle fatigue, reduced endurance, and impaired physical performance. Studies have shown that dietary interventions with antioxidant and anti-inflammatory properties may enhance muscle function, improve aerobic capacity, and accelerate post-exercise recovery. Given the documented antioxidant and anti-inflammatory activities of TMM, supplementation with TMM may help attenuate exercise-induced physiological stress, preserve muscle function, and enhance overall physical performance.

Although several studies have investigated the pharmacological properties of TMM and its effects on respiratory health, immunity, and antioxidant status, clinical evidence regarding its efficacy in improving physical performance remains limited. A previous randomized controlled trial reported beneficial effects of TMM supplementation combined with resistance training on muscular strength, aerobic fitness, anaerobic performance, and immune parameters in young adults. However, further studies are required to better understand the effects of TMM supplementation on physical performance, cardiovascular endurance, exercise recovery, inflammatory responses, and perceived wellbeing in healthy individuals.

Therefore, this study aims to evaluate the effects of Tiger Milk Mushroom supplementation on physical performance among healthy adults by assessing muscle strength, cardiovascular endurance, exercise-related inflammatory markers, stress levels, and overall wellbeing.

Being tested
Tiger Milk Mushroom (TMM), Placebo
Keywords
Tiger Milk Mushroom, Lignosus rhinocerus, Physical Performance, Muscle Strength, Endurance Performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tiger Milk Mushroom (TMM)Dietary supplement

    Participants received Tiger Milk Mushroom (Lignosus rhinocerus) capsules containing 300 mg of TMM extract per capsule. Participants consumed one capsule orally twice daily for 12 weeks.

  • PlaceboDietary supplement

    Participants received matching placebo capsules identical in appearance to the active supplement. Participants consumed one capsule orally twice daily for 12 weeks.

Study groups in NCT07756788
Study groupRoleWhat they receive
Tiger Milk Mushroom (TMM)ExperimentalParticipants in this arm consumed Tiger Milk Mushroom (Lignosus rhinocerus) supplementation at a dosage of one capsule (300mg) twice daily for 12 weeks. Physical performance, cardiovascular endurance, inflammatory biomarkers, stress levels, and overall wellbeing were assessed at baseline, week 6, and week 12.
Receives: Dietary Supplement: Tiger Milk Mushroom (TMM)
PlaceboPlacebo comparatorParticipants in this arm consumed matching placebo capsules at a dosage of one capsule twice daily for 12 weeks. The placebo capsules were identical in appearance to the active supplement. Physical performance, cardiovascular endurance, inflammatory biomarkers, stress levels, and overall wellbeing were assessed at baseline, week 6, and week 12.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Maximal Oxygen Uptake (VO₂max)

    Change in estimated maximal oxygen uptake (VO₂max), an indicator of aerobic capacity and cardiovascular endurance. VO₂max was estimated using the Rockport One-Mile Walk Test based on walk completion time, post-exercise heart rate, age, sex, and body weight.

    Measured: Baseline, Week 6, and Week 12

  2. Change in Isometric Muscle Strength

    Muscle strength (kgf) of the elbow flexors, wrist extensors, shoulder abductors, hip flexors, knee extensors, and foot dorsiflexors was measured using a handheld muscle assessment dynamometer. Higher values indicate greater muscle strength (better outcome).

    Measured: Baseline, Week 6, and Week 12

  3. Change in Rating of Perceived Exertion (RPE)

    Rate of perceived exertion (RPE) was assessed using the Borg Category-Ratio 10 (CR10) Scale, with scores ranging from 0 to 10, where 0 indicates no exertion and 10 indicates maximal exertion. Lower scores indicate lower perceived exertion (better outcome), whereas higher scores indicate greater perceived exertion (worse outcome).

    Measured: Baseline, Week 6, and Week 12

Secondary outcomes (14)
  1. Change in Total Iron Binding Capacity (TIBC)

    Total iron-binding capacity (TIBC) (mg/L) was measured using an enzyme-linked immunosorbent assay (ELISA). TIBC was assessed as an indicator of iron-binding capacity and oxygen transport potential. Higher values indicate greater iron-binding capacity.

    Measured: Baseline, and Week 12

  2. Change in Serum Cortisol Levels

    Salivary cortisol concentration (ng/mL) was measured using an enzyme-linked immunosorbent assay (ELISA). Lower concentrations indicate lower physiological stress (better outcome).

    Measured: Baseline, Week 6, and Week 12

  3. Change in Creatine Kinase Levels

    Serum creatine kinase (CK) concentration (U/L) was measured using an enzyme-linked immunosorbent assay (ELISA). CK concentration was assessed as a biomarker of exercise-induced muscle damage. Lower CK concentrations indicate reduced muscle damage (better outcome).

    Measured: Baseline, and Week 12

  4. Changes in Lactate Levels

    Blood lactate concentration (mg/dL) was measured using an enzyme-linked immunosorbent assay (ELISA). Lower concentrations indicate reduced metabolic fatigue and improved exercise recovery (better outcome).

    Measured: Baseline and week 12

  5. Change in Inflammatory Levels

    Serum interleukin-2 (IL-2) and interleukin-6 (IL-6) concentrations (pg/mL) were measured using enzyme-linked immunosorbent assays (ELISA) to assess immune and inflammatory responses following Tiger Milk Mushroom supplementation.

    Measured: Baseline, and Week 12

  6. Change in Perceived Stress Scale (PSS-10) Score

    Perceived Stress Scale-10 (PSS-10) score. The PSS-10 consists of 10 items scored on a 5-point Likert scale (0-4), with a total score ranging from 0 to 40. Higher scores indicate greater perceived stress (worse outcome), whereas lower scores indicate lower perceived stress (better outcome).

    Measured: Baseline, Week 6, and Week 12

  7. Change in Visual Analogue Scale (VAS) Score on Physical Fitness

    Visual Analogue Scale (VAS) for Exercise Performance: Participants rated their overall perceived exercise performance using a 10-point Visual Analogue Scale (VAS). Scores range from 1 to 10, with 1 indicating the poorest perceived exercise performance and 10 indicating the best perceived exercise performance. Higher scores indicate better perceived exercise performance (better outcome).

    Measured: Baseline, Week 6, and Week 12

  8. Red Blood Cell Count

    Red blood cell (RBC) count (×10⁶/µL) measured using an automated hematology analyzer. RBC count was assessed to evaluate the hematological safety of Tiger Milk Mushroom supplementation.

    Measured: Baseline and Week 12

  9. White Blood Cell Count

    White blood cell (WBC) count (×10³/µL) measured using an automated hematology analyzer. WBC count was assessed to evaluate the hematological safety of Tiger Milk Mushroom supplementation.

    Measured: Baseline and Week 12

  10. Platelet Count

    Platelet count (×10³/µL) measured using an automated hematology analyzer. Platelet count was assessed to evaluate the hematological safety of Tiger Milk Mushroom supplementation.

    Measured: Baseline and Week 12

  11. Hepatic Function

    Hepatic function was assessed by measuring serum alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) activities (U/L) using an automated clinical chemistry analyzer. These parameters were evaluated to assess the hepatic safety of Tiger Milk Mushroom supplementation.

    Measured: Baseline and week 12

  12. Blood Urea Nitrogen (BUN) Concentration

    Blood urea nitrogen (BUN) concentration (mmol/L) measured using an automated clinical chemistry analyzer. BUN concentration was assessed to evaluate renal safety following Tiger Milk Mushroom supplementation.

    Measured: Baseline and week 12

  13. Serum Creatinine Concentration

    Serum creatinine concentration (µmol/L) measured using an automated clinical chemistry analyzer. Serum creatinine concentration was assessed to evaluate renal safety following Tiger Milk Mushroom supplementation.

    Measured: Baseline and week 12

  14. Estimated Glomerular Filtration Rate (eGFR)

    Estimated glomerular filtration rate (eGFR) (mL/min/1.73 m²) calculated from serum creatinine using a validated equation and reported by the clinical laboratory. eGFR was assessed to evaluate renal function and the renal safety of Tiger Milk Mushroom supplementation.

    Measured: Baseline and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 May 2026

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to receive either Tiger Milk Mushroom (TMM) supplementation or a matching placebo for 12 weeks. Participants will remain in their assigned intervention group throughout the study period.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07756788
Sponsor's protocol ID
IEC-2024-FMHS-0006
Status last verified
Aug 2026
First submitted
28 Jul 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data underlying the results reported in publications arising from this study, after de-identification, may be made available upon reasonable request to the Principal Investigator.

Publications

  • Tan ESS, Leo TK, Tan CK. Effect of tiger milk mushroom (Lignosus rhinocerus) supplementation on respiratory health, immunity and antioxidant status: an open-label prospective study. Sci Rep. 2021 Jun 3;11(1):11781. doi: 10.1038/s41598-021-91256-6.

    PubMed 34083710
  • Chen CK, Hamdan NF, Ooi FK, Wan Abd Hamid WZ. Combined Effects of Lignosus rhinocerotis Supplementation and Resistance Training on Isokinetic Muscular Strength and Power, Anaerobic and Aerobic Fitness Level, and Immune Parameters in Young Males. Int J Prev Med. 2016 Sep 14;7:107. doi: 10.4103/2008-7802.190604. eCollection 2016.

    PubMed 27833721

Questions about this trial

What is this clinical trial studying?

A study testing Tiger Milk Mushroom (TMM) in people with Physical Performances and Physical Fitness, run by Nexus Wise Sdn Bhd at 1 site in Malaysia.

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 5 inclusion and 10 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 11 Aug 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 Malaysia. 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 Maximal Oxygen Uptake (VO₂max) (time frame: Baseline, Week 6, and Week 12). The study lists 3 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 NCT07756788, 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 11 Aug 2026.

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