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

NCT07756788 | Completed

• 1 other identifier: IEC-2024-FMHS-0006
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Physical Performances; Physical Fitness; Exercise Capacity

Keywords

Tiger Milk Mushroom; Lignosus rhinocerus; Physical Performance; Muscle Strength; Endurance Performance

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, Week 6, and Week 12

• 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).

  Baseline, Week 6, and Week 12

• 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).

  Baseline, Week 6, and Week 12

Secondary Outcomes (14)

• Change in Total Iron Binding Capacity (TIBC)

  Baseline, and Week 12

• Change in Serum Cortisol Levels

  Baseline, Week 6, and Week 12

• Change in Creatine Kinase Levels

  Baseline, and Week 12

• Changes in Lactate Levels

  Baseline and week 12

• Change in Inflammatory Levels

  Baseline, and Week 12

Study Arms (2)

Tiger Milk Mushroom (TMM)

EXPERIMENTAL

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.

Dietary Supplement: Tiger Milk Mushroom (TMM)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

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.

Tiger Milk Mushroom (TMM)

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nexus Wise Sdn Bhd: lead
• UCSI University: collaborator

Study Sites (1)

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 34083710 BACKGROUND

• 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.

  PMID: 27833721 BACKGROUND

Study Officials

• Chung Keat Tan, PhD

  UCSI University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors were blinded to treatment allocation throughout the study. Active and placebo capsules were identical in appearance, packaging, and administration schedule. Treatment allocation codes remained concealed until completion of data collection and statistical analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 11, 2026
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: May 31, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

MY (1)