An interventional study of Lactiplantibacillus plantarum LM1001 and Placebo in Age-Related Muscle Weakness, sponsored by Lactomason Co., Ltd.. Recruiting at 1 site in South Korea. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Lactomason Co., Ltd. · Not applicable, Interventional, and Supportive care
Purpose:
This clinical trial aims to evaluate the efficacy and safety of Lactiplantibacillus plantarum LM1001 in improving muscle strength in older adults. The study is designed to investigate its potential effects on muscle strength based on the gut-muscle axis.
Methodology:
This study is a randomized, double-blind, placebo-controlled, single-center clinical trial. A total of 100 participants will be enrolled and randomly assigned to either the test group (n=50) or the placebo group (n=50). Participants in the test group will receive 500 mg of Lactiplantibacillus plantarum LM1001 (1.0 × 10¹⁰ CFU/day) once daily for 12 weeks, while those in the placebo group will receive a matching placebo.
Key Outcome Measures:
To evaluate the effects on muscle strength, the following parameters will be assessed at baseline and after the 12-week intervention period:
- Primary Outcome Measures: Changes in isokinetic knee extension and flexion strength.
- Secondary Outcome Measures: Changes in muscle strength-related parameters, including muscle power, skeletal muscle mass (SMM), and skeletal muscle mass index (SMI), as well as physical performance measures such as handgrip strength, Short Physical Performance Battery (SPPB) score, Timed Up and Go (TUG) test, and health-related quality of life assessed by EQ-5D-5L.
- Safety Assessments: Safety will be evaluated based on the incidence of adverse events, serum biochemical parameters, and clinical laboratory test results.
Lactomason Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will take one capsule containing 500 mg of Lactiplantibacillus plantarum LM1001 (1.0 x 10\^10 CFU/day) once daily, once daily in the morning before breakfast with sufficient water throughout the study period.
Dietary Supplement: Lactiplantibacillus plantarum LM1001
Participants in this arm will take one placebo capsule (containing processed starch, etc.) identical in appearance to the test product, once daily in the morning before breakfast with sufficient water throughout the study period.
Dietary Supplement: Placebo
A 500 mg capsule containing Lactiplantibacillus plantarum LM1001 (1.0 x 10\^10 CFU/day).
An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.
Change in quadriceps and hamstring muscle strength (left and right)
Change from baseline in quadriceps and hamstring muscle strength (left and right), measured using Biodex at an angular velocity of 60°/s.
Time frame: Baseline and Week 12
Change in Muscle power
Change from baseline in Muscle power measured by Biodex at an angular velocity of 60°/s
Time frame: Baseline and Week 12
Change in Absolute skeletal muscle mass (SM)
Change from baseline in Absolute skeletal muscle mass (SM) measured by bioelectrical impedance analysis (BIA)
Time frame: Baseline and Week 12
Change in Appendicular skeletal muscle mass index (ASM/height²)
Change from baseline in Appendicular skeletal muscle mass index (ASM/height²) measured by BIA
Time frame: Baseline and Week 12
Change in Total body fat percentage
Change from baseline in Total body fat percentage measured by BIA
Time frame: Baseline and Week 12
Change in ASM/weight × 100
Change from baseline in ASM/weight × 100 measured by BIA
Time frame: Baseline and Week 12
Change in Skeletal muscle mass index (SMM/height²)
Change from baseline in Skeletal muscle mass index (SMM/height²) measured by BIA
Time frame: Baseline and Week 12
Change in Handgrip strength
Change from baseline in Handgrip strength measured by hand dynamometer
Time frame: Baseline and Week 12
Change in Short Physical Performance Battery (SPPB) score
Change from baseline in Short Physical Performance Battery (SPPB) total score (range 0-12; higher scores indicate better physical performance) and subscores: balance (0-4), gait speed (0-4), and chair stand (0-4)
Time frame: Baseline and Week 12
Change in Timed Up and Go (TUG) test
Change from baseline in functional mobility based on the time taken to stand, walk, turn, and return to a seated position.
Time frame: Baseline and Week 12
Change in Serum creatinine levels
Change from baseline in serum creatinine concentration
Time frame: Baseline and Week 12
Change in Serum total protein levels
Change from baseline in serum total protein concentration
Time frame: Baseline and Week 12
Change in Serum albumin levels
Change from baseline in serum albumin concentration
Time frame: Baseline and Week 12
Change in Serum prealbumin levels
Change from baseline in serum prealbumin concentration
Time frame: Baseline and Week 12
Change in Serum C-reactive protein (CRP) levels
Change from baseline in serum C-reactive protein (CRP) concentration
Time frame: Baseline and Week 12
Change in Serum creatine kinase (CK) levels
Change from baseline in serum creatine kinase (CK) concentration
Time frame: Baseline and Week 12
Change in Health-related quality of life assessed by EQ-5D-5L
Change from baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) index score (range -0.5 to 1.0; higher scores indicate better health-related quality of life)
Time frame: Baseline and Week 12
Plan to share: No
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Lactomason Co., Ltd.