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

NCT06893549 | Completed

• 1 other identifier: IRB-24-034-A2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Probiotic Supplement; Exercise Fatigue; Lactiplantibacillus paraplantarum GKK1; Physical Performance; Muscle Damage; Recovery; Anaerobic Power; Explosive Power; Isometric Strength; Sports Nutrition

Outcome Measures

Primary Outcomes (1)

• Change in Anaerobic Power

  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.

  Time Frame: Day 0 (baseline), Day 29 before exercise, Day 29 three hours after exercise, and Day 30 twenty-four hours after exercise

Secondary Outcomes (7)

• 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

Study Arms (2)

Lactobacillus plantarum GKK1 Probiotic Group

EXPERIMENTAL

Participants in this 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. On Day 29, participants will undergo an exhaustive exercise test, and various physiological and biochemical markers will be assessed pre- and post-exercise.

Dietary Supplement: Lactobacillus plantarum GKK1 Probiotic

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive a daily oral supplementation of placebo capsules for 28 days. The placebo capsules contain microcrystalline α-cellulose, magnesium stearate, and silicon dioxide, with identical appearance and taste to the probiotic capsules. On Day 29, participants will undergo an exhaustive exercise test, and various physiological and biochemical markers will be assessed pre- and post-exercise.

Dietary Supplement: Placebo

Interventions

Lactobacillus plantarum GKK1 Probiotic DIETARY_SUPPLEMENT

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.

Also known as: Probiotic Supplement

Lactobacillus plantarum GKK1 Probiotic Group

Placebo DIETARY_SUPPLEMENT

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.

Also known as: Placebo Supplement

Placebo Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan Sport University: lead
• Grape King Bio Ltd.: collaborator

Study Sites (1)

National Taiwan Sport University

Taoyuan, 333, Taiwan

Location

Related Publications (1)

• Lee MC, Hsu YJ, Ho CS, Chang CH, Liu CW, Huang CC, Chiang WD. Evaluation of the Efficacy of Supplementation with Planox(R) Lemon Verbena Extract in Improving Oxidative Stress and Muscle Damage: A Randomized Double-Blind Controlled Trial. Int J Med Sci. 2021 May 3;18(12):2641-2652. doi: 10.7150/ijms.60726. eCollection 2021.

  PMID: 34104096 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind, meaning that the participants, care providers, investigators, and outcomes assessors are unaware of the assigned interventions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a randomized, double-blind, placebo-controlled parallel-group trial comparing the effects of Lactobacillus plantarum GKK1 supplementation with a placebo in healthy adults.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 25, 2025
• Study Start: September 24, 2024
• Primary Completion: November 1, 2024
• Study Completion: March 14, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)