Age-Related Muscle Weakness
Conditions
Keywords
probiotics, Lactiplantibacillus plantarum, Age-related muscle weakness, Gut-muscle axis
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLactiplantibacillus plantarum LM1001
A 500 mg capsule containing Lactiplantibacillus plantarum LM1001 (1.0 x 10\^10 CFU/day).
DIETARY_SUPPLEMENTPlacebo
An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.
Sponsors
Lactomason Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care provider, investigators, and outcome assessors are blinded to the group allocation. The investigational product and placebo are identical in appearance, taste, and packaging.
Intervention model description
Participants are randomly assigned to either the probiotic group or the placebo group and receive the assigned intervention for 12 weeks.
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 50 to 84 years (male or female) * Body mass index (BMI) between 18.5 and 30.0 kg/m² * Reduced skeletal muscle mass (≤110% of standard value by BIA) * Decreased handgrip strength according to age- and sex-specific criteria * Short Physical Performance Battery (SPPB) score over 9 * Able to perform normal physical activity and provide written informed consent
Exclusion criteria
* Clinically significant acute or chronic diseases requiring treatment * Conditions affecting muscle function or physical performance (e.g., severe musculoskeletal, neurological, or cognitive disorders, including sarcopenia) * Significant gastrointestinal disorders or history of major gastrointestinal surgery * Severe psychiatric disorders or recent use of antipsychotic medications * Respiratory diseases affecting lung function * Excessive alcohol intake, substance abuse, or heavy smoking * Known hypersensitivity to the investigational product or its components * Recent use of medications or supplements affecting muscle function or gut microbiota (e.g., antibiotics, probiotics, steroids) * Regular high-intensity or resistance exercise * Clinically significant abnormal laboratory findings or uncontrolled medical conditions * Recent fractures within the past year * Participation in another clinical trial within 3 months prior to screening * Pregnant or breastfeeding women * Individuals unable to communicate or ambulate * Any other condition deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quadriceps and hamstring muscle strength (left and right) | Baseline and Week 12 | Change from baseline in quadriceps and hamstring muscle strength (left and right), measured using Biodex at an angular velocity of 60°/s. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle power | Baseline and Week 12 | Change from baseline in Muscle power measured by Biodex at an angular velocity of 60°/s |
| Change in Absolute skeletal muscle mass (SM) | Baseline and Week 12 | Change from baseline in Absolute skeletal muscle mass (SM) measured by bioelectrical impedance analysis (BIA) |
| Change in Appendicular skeletal muscle mass index (ASM/height²) | Baseline and Week 12 | Change from baseline in Appendicular skeletal muscle mass index (ASM/height²) measured by BIA |
| Change in Total body fat percentage | Baseline and Week 12 | Change from baseline in Total body fat percentage measured by BIA |
| Change in ASM/weight × 100 | Baseline and Week 12 | Change from baseline in ASM/weight × 100 measured by BIA |
| Change in Skeletal muscle mass index (SMM/height²) | Baseline and Week 12 | Change from baseline in Skeletal muscle mass index (SMM/height²) measured by BIA |
| Change in Handgrip strength | Baseline and Week 12 | Change from baseline in Handgrip strength measured by hand dynamometer |
| Change in Short Physical Performance Battery (SPPB) score | Baseline and Week 12 | 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) |
| Change in Timed Up and Go (TUG) test | Baseline and Week 12 | Change from baseline in functional mobility based on the time taken to stand, walk, turn, and return to a seated position. |
| Change in Serum creatinine levels | Baseline and Week 12 | Change from baseline in serum creatinine concentration |
| Change in Serum total protein levels | Baseline and Week 12 | Change from baseline in serum total protein concentration |
| Change in Serum albumin levels | Baseline and Week 12 | Change from baseline in serum albumin concentration |
| Change in Serum prealbumin levels | Baseline and Week 12 | Change from baseline in serum prealbumin concentration |
| Change in Serum C-reactive protein (CRP) levels | Baseline and Week 12 | Change from baseline in serum C-reactive protein (CRP) concentration |
| Change in Serum creatine kinase (CK) levels | Baseline and Week 12 | Change from baseline in serum creatine kinase (CK) concentration |
| Change in Health-related quality of life assessed by EQ-5D-5L | Baseline and Week 12 | 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) |
Countries
South Korea
Contacts
CONTACTYoon Ju So
CONTACTEunju Lim
PRINCIPAL_INVESTIGATORMyung Jun Shin, Ph.D.
Pusan National University Hospital
Outcome results
None listed