NCT06893549

Effect of Lactobacillus Plantarum GKK1 Supplementation on Anti-fatigue Health Effects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Taiwan Sport University · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Title: Effect of Lactobacillus plantarum GKK1 Supplementation on Anti-Fatigue Health Effects: A Randomized, Double-Blind, Placebo-Controlled Trial This study aims to investigate the effects of Lactobacillus plantarum GKK1 supplementation on fatigue reduction and physical performance enhancement in healthy adults. Probiotics are known to modulate gut microbiota and may influence exercise-induced fatigue and recovery. A total of 48 healthy adults aged 18-35 years will be randomly assigned to either the probiotic group (Lactobacillus plantarum GKK1, 100 billion CFU/day) or the placebo group, with supplementation for 28 consecutive days. On Day 29, participants will perform an exhaustive exercise test, and their anaerobic power, explosive power, isometric muscle strength, and stress hormone levels (cortisol, catecholamines, GH, testosterone, hs-CRP) will be evaluated before and after exercise. The primary objective is to assess whether probiotic supplementation can reduce exercise-induced fatigue and muscle damage while improving recovery performance. Blood biochemical markers, muscle damage indicators, and subjective fatigue perception will also be analyzed. This study is conducted at National Taiwan Sport University, under ethical approval from Landseed Hospital IRB (IRB-24-034-A2).

Detailed description

Probiotic supplementation has garnered increasing interest in sports science due to its potential effects on gut microbiota modulation, systemic inflammation, and exercise recovery. Lactobacillus plantarum GKK1, a strain isolated from fermented plant sources, exhibits promising antioxidative and anti-inflammatory properties, making it a candidate for supporting physical resilience and fatigue recovery in active individuals. This study is designed as a randomized, double-blind, placebo-controlled clinical trial aiming to evaluate whether supplementation with L. plantarum GKK1 can attenuate physiological stress responses and muscle damage following exhaustive exercise in healthy adults. The probiotic intervention lasts for 28 consecutive days, during which participants maintain habitual dietary and lifestyle behaviors, except for the avoidance of other functional supplements. The experimental exercise model includes a structured fatigue-inducing protocol involving repetitive plyometric movements. This model was selected to simulate high-intensity sport-like conditions while reliably inducing measurable muscle stress. Following this challenge, blood and urine samples are collected at predefined time points to monitor temporal changes in selected biochemical markers. The trial incorporates both objective and subjective metrics, including validated physical performance tests and standardized fatigue perception scales. Biochemical assessments are conducted using automated clinical analyzers and immunoassay techniques under Good Laboratory Practice conditions. The core hypothesis posits that probiotic intervention will result in lower elevations in stress hormones and muscle damage biomarkers, along with improved physical performance maintenance compared to placebo. All procedures are conducted at the National Taiwan Sport University under IRB approval (IRB-24-034-A2). This trial may provide evidence for the application of probiotic supplementation as a supportive strategy for fatigue management and exercise recovery enhancement in recreationally active populations.

Conditions

• Exercise-Induced Fatigue
• Muscle Fatigue
• Sports Performance
• Fatigue Recovery

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus plantarum GKK1 Probiotic	Participants in the probiotic group will receive a daily oral supplementation of Lactobacillus plantarum GKK1 probiotic capsules for 28 days. Each capsule contains 50 billion CFU, with a total daily intake of 100 billion CFU. The probiotic strain Lactobacillus plantarum GKK1 has been selected for its potential benefits in reducing exercise-induced fatigue and enhancing physical performance. The supplementation period will be followed by an exhaustive exercise test to assess physiological and biochemical changes.
DIETARY_SUPPLEMENT	Placebo	Participants in the placebo group will receive a daily oral supplementation of placebo capsules for 28 days. The placebo capsules are identical in appearance, taste, and weight to the probiotic capsules but contain only microcrystalline α-cellulose, magnesium stearate, and silicon dioxide. The supplementation period will be followed by an exhaustive exercise test to assess physiological and biochemical changes.

Timeline

• Start date: 2024-09-24
• Primary completion: 2024-11-01
• Completion: 2025-03-14
• First posted: 2025-03-25
• Last updated: 2025-03-26

Locations

1 site across 1 country: Taiwan