Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

8. august 2026 opdateret af: Nexus Wise Sdn Bhd

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.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • UCSI University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tiger Milk Mushroom (TMM)
Participants 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.
Kosttilskud: Tiger Milk Mushroom (TMM)
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.
Placebo komparator: Placebo
Participants 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.
Kosttilskud: Placebo
Participants received matching placebo capsules identical in appearance to the active supplement. Participants consumed one capsule orally twice daily for 12 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Maximal Oxygen Uptake (VO₂max)
Tidsramme: Baseline, Week 6, and Week 12
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.
Baseline, Week 6, and Week 12
Change in Isometric Muscle Strength
Tidsramme: Baseline, Week 6, and Week 12
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).
Baseline, Week 6, and Week 12
Change in Rating of Perceived Exertion (RPE)
Tidsramme: Baseline, Week 6, and Week 12
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).
Baseline, Week 6, and Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Total Iron Binding Capacity (TIBC)
Tidsramme: Baseline, and Week 12
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.
Baseline, and Week 12
Change in Serum Cortisol Levels
Tidsramme: Baseline, Week 6, and Week 12
Salivary cortisol concentration (ng/mL) was measured using an enzyme-linked immunosorbent assay (ELISA). Lower concentrations indicate lower physiological stress (better outcome).
Baseline, Week 6, and Week 12
Change in Creatine Kinase Levels
Tidsramme: Baseline, and Week 12
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).
Baseline, and Week 12
Changes in Lactate Levels
Tidsramme: Baseline and week 12
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).
Baseline and week 12
Change in Inflammatory Levels
Tidsramme: Baseline, and Week 12
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.
Baseline, and Week 12
Change in Perceived Stress Scale (PSS-10) Score
Tidsramme: Baseline, Week 6, and Week 12
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).
Baseline, Week 6, and Week 12
Change in Visual Analogue Scale (VAS) Score on Physical Fitness
Tidsramme: Baseline, Week 6, and Week 12
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).
Baseline, Week 6, and Week 12
Red Blood Cell Count
Tidsramme: Baseline and Week 12
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.
Baseline and Week 12
White Blood Cell Count
Tidsramme: Baseline and Week 12
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.
Baseline and Week 12
Platelet Count
Tidsramme: Baseline and Week 12
Platelet count (×10³/µL) measured using an automated hematology analyzer. Platelet count was assessed to evaluate the hematological safety of Tiger Milk Mushroom supplementation.
Baseline and Week 12
Hepatic Function
Tidsramme: Baseline and week 12
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.
Baseline and week 12
Blood Urea Nitrogen (BUN) Concentration
Tidsramme: Baseline and week 12
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.
Baseline and week 12
Serum Creatinine Concentration
Tidsramme: Baseline and week 12
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.
Baseline and week 12
Estimated Glomerular Filtration Rate (eGFR)
Tidsramme: Baseline and week 12
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.
Baseline and week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nexus Wise Sdn Bhd

Samarbejdspartnere

UCSI University

Efterforskere

  • Ledende efterforsker: Chung Keat Tan, PhD, UCSI University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2025

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Faktiske)

31. maj 2026

Datoer for studieregistrering

Først indsendt

28. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. august 2026

Først opslået (Faktiske)

11. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IEC-2024-FMHS-0006

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study investigators may gain access to the data. Requests should be directed to the Principal Investigator. Data will be shared following review and approval of the request and execution of an appropriate data sharing agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner