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

Not Applicable

Completed

• Conditions: Exercise-Induced Fatigue; Muscle Fatigue; Sports Performance; Fatigue Recovery

• Registration Number: NCT06893549
• Lead Sponsor: National Taiwan Sport University

Brief 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.

Study Timeline

• Study Start: 2024-09-24
• Primary Completion: 2024-11-01
• Status Verified: 2025-03
• Study Completion: 2025-03-14
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-22
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Anaerobic Power	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.

Secondary Outcome Measures

Name	Time	Method
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	Serum cortisol levels (nmol/L) will be measured using enzyme-linked immunosorbent assay (ELISA). Cortisol is a biomarker of physiological stress and fatigue. Changes in cortisol concentration will be used to assess the participant's stress response to exhaustive 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	Serum catecholamines (epinephrine, norepinephrine, and dopamine) will be measured using high-performance liquid chromatography (HPLC). These biomarkers reflect sympathetic nervous system activity and are associated with exercise-induced stress and fatigue.
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	High-sensitivity C-reactive protein (hs-CRP) will be measured in serum (mg/L) using ELISA. hs-CRP is a marker of systemic inflammation and may increase in response to intense physical stress. This measurement helps assess the anti-inflammatory effect of probiotic supplementation.
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	Serum creatine kinase (CK) activity (U/L) will be assessed using an automated biochemical analyzer. CK is a widely used marker of muscle damage following intense exercise. Elevated levels may indicate muscle cell injury.
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	Serum myoglobin (ng/mL) will be measured using a commercial assay kit. Myoglobin is released into the blood following muscle damage and is used as an early indicator of exercise-induced muscle injury.
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	Urinary 3-methylhistidine concentration will be measured as a biomarker of muscle protein breakdown. The ratio of 3-methylhistidine to creatinine (μmol/mmol) will be used to assess muscle catabolism post-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	Subjective fatigue perception will be assessed using a 10-point visual analog scale, where 0 indicates no fatigue and 10 indicates extreme fatigue. Participants will rate their perceived fatigue at specified time points to evaluate recovery.

Trial Locations

Locations (1)

National Taiwan Sport University; 🇨🇳 Taoyuan City, Taiwan