Effect of Lactobacillus Plantarum GKK1 Supplementation on Anti-fatigue Health Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Anaerobic Power
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study is double-blind, meaning that the participants, care providers, investigators, and outcomes assessors are unaware of the assigned interventions.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18 to 35 years
- •Non-smokers and non-alcohol drinkers
- •No history of chronic disease (e.g., cardiovascular disease, diabetes, asthma, metabolic disorders)
- •No musculoskeletal injuries in the past 6 months
- •Not taking anti-inflammatory or pain-relief medication in the past month
- •No history of gastrointestinal surgery (excluding hernia or polyp removal)
- •No allergies to dairy or probiotics
排除标准
- •Diagnosed with cardiovascular, metabolic, or neurological disorders
- •Regular consumption of probiotics within the last three months
- •Pregnant or lactating women
- •Individuals taking medication affecting hormonal balance or immune response
- •Use of corticosteroids, NSAIDs, or muscle relaxants in the past month
- •Participating in another clinical trial within the last three months
结局指标
主要结局
Change in Anaerobic Power
时间窗: Time Frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise
Anaerobic power will be assessed using a Wingate anaerobic test. Measurements include peak power (W/kg), average power (W/kg), and fatigue index (%). Higher values indicate better performance and lower fatigue.
次要结局
- Change in Cortisol Levels(Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise)
- Change in Catecholamines Levels(Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise)
- Change in hs-CRP Levels(Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise)
- Change in Creatine Kinase (CK)(Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise)
- Change in Myoglobin Levels(Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise)
- Change in 3-Methylhistidine Levels(Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise)
- Change in Subjective Fatigue Perception Score(Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise)
研究者
Chi-Chang Huang
Professor
National Taiwan Sport University