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Effects of TM02® Supplementation on Immune Function in Children
Sponsor: Ligno Biotech Sdn. Bhd.
Summary
This randomized, double-blind, placebo-controlled clinical study evaluated the effects of 12 weeks of TM02® supplementation on immune-related outcomes in generally healthy children aged 2 to 12 years. Participants were randomized to receive either TM02® or a matching placebo for 12 weeks. Immune-related assessments were performed at baseline and at Weeks 4, 8, and 12. Outcomes included salivary immunoglobulin A (IgA), interleukin-2 (IL-2), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), the Immune Status Questionnaire (ISQ), and Visual Analogue Scale (VAS) for immunity status, when participants experienced illness. Safety and tolerability were monitored throughout the study.
Official title: Beneficial Effects of TM02® Supplementation in Improving Immunity Among Children: A Randomized, Double-Blind, Placebo-Controlled Trial
Key Details
Gender
All
Age Range
2 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2025-06-01
Completion Date
2025-11-30
Last Updated
2026-10-02
Healthy Volunteers
Yes
Conditions
Interventions
TM02®
TM02® was provided as a chewable tablet containing 125 mg Tiger Milk Mushroom together with mixed berry juice powder and other excipients. Participants consumed one tablet twice daily for 12 weeks, providing a total daily TM02® dose of 250 mg.
Placebo
Matching chewable placebo containing the same excipients as the intervention product but without TM02®. Participants consumed one tablet twice daily for 12 weeks.
Locations (1)
UCSI University
Cheras, Kuala Lumpur, Malaysia