Effects of Tiger Milk Mushroom Supplementation on Physical Performance in Physically Active Adults
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malasia, 56000
- UCSI University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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.
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Comparador de placebos: 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.
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Participants received matching placebo capsules identical in appearance to the active supplement.
Participants consumed one capsule orally twice daily for 12 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Maximal Oxygen Uptake (VO₂max)
Periodo de tiempo: Baseline, Week 6, and Week 12
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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.
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Baseline, Week 6, and Week 12
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Change in Isometric Muscle Strength
Periodo de tiempo: Baseline, Week 6, and Week 12
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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).
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Baseline, Week 6, and Week 12
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Change in Rating of Perceived Exertion (RPE)
Periodo de tiempo: Baseline, Week 6, and Week 12
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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).
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Baseline, Week 6, and Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Total Iron Binding Capacity (TIBC)
Periodo de tiempo: Baseline, and Week 12
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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.
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Baseline, and Week 12
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Change in Serum Cortisol Levels
Periodo de tiempo: Baseline, Week 6, and Week 12
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Salivary cortisol concentration (ng/mL) was measured using an enzyme-linked immunosorbent assay (ELISA).
Lower concentrations indicate lower physiological stress (better outcome).
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Baseline, Week 6, and Week 12
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Change in Creatine Kinase Levels
Periodo de tiempo: Baseline, and Week 12
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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).
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Baseline, and Week 12
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Changes in Lactate Levels
Periodo de tiempo: Baseline and week 12
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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).
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Baseline and week 12
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Change in Inflammatory Levels
Periodo de tiempo: Baseline, and Week 12
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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.
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Baseline, and Week 12
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Change in Perceived Stress Scale (PSS-10) Score
Periodo de tiempo: Baseline, Week 6, and Week 12
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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).
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Baseline, Week 6, and Week 12
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Change in Visual Analogue Scale (VAS) Score on Physical Fitness
Periodo de tiempo: Baseline, Week 6, and Week 12
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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).
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Baseline, Week 6, and Week 12
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Red Blood Cell Count
Periodo de tiempo: Baseline and Week 12
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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.
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Baseline and Week 12
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White Blood Cell Count
Periodo de tiempo: Baseline and Week 12
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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.
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Baseline and Week 12
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Platelet Count
Periodo de tiempo: Baseline and Week 12
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Platelet count (×10³/µL) measured using an automated hematology analyzer.
Platelet count was assessed to evaluate the hematological safety of Tiger Milk Mushroom supplementation.
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Baseline and Week 12
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Hepatic Function
Periodo de tiempo: Baseline and week 12
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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.
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Baseline and week 12
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Blood Urea Nitrogen (BUN) Concentration
Periodo de tiempo: Baseline and week 12
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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.
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Baseline and week 12
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Serum Creatinine Concentration
Periodo de tiempo: Baseline and week 12
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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.
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Baseline and week 12
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Estimated Glomerular Filtration Rate (eGFR)
Periodo de tiempo: Baseline and week 12
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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.
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Baseline and week 12
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chung Keat Tan, PhD, UCSI University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IEC-2024-FMHS-0006
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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