Effect of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactiplantibacillus plantarum LM1001, Placebo.
- Who it may be relevant to
- Registry conditions: Age-Related Muscle Weakness. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effects of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults.
Overview
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 supplement Lactiplantibacillus plantarum LM1001
A 500 mg capsule containing Lactiplantibacillus plantarum LM1001 (1.0 x 10\^10 CFU/day). - Dietary supplement Placebo
An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.
Primary outcome measures
- Change in quadriceps and hamstring muscle strength (left and right) [Time frame: Baseline and Week 12]
Secondary outcome measures (12)
- Change in Muscle power [Time frame: Baseline and Week 12]
- Change in Absolute skeletal muscle mass (SM) [Time frame: Baseline and Week 12]
- Change in Appendicular skeletal muscle mass index (ASM/height²) [Time frame: Baseline and Week 12]
- Change in Total body fat percentage [Time frame: Baseline and Week 12]
- Change in ASM/weight × 100 [Time frame: Baseline and Week 12]
- Change in Skeletal muscle mass index (SMM/height²) [Time frame: Baseline and Week 12]
- Change in Handgrip strength [Time frame: Baseline and Week 12]
- Change in Short Physical Performance Battery (SPPB) score [Time frame: Baseline and Week 12]
- Change in Timed Up and Go (TUG) test [Time frame: Baseline and Week 12]
- Change in Serum creatinine levels [Time frame: Baseline and Week 12]
- Change in Serum total protein levels [Time frame: Baseline and Week 12]
- Change in Serum albumin levels [Time frame: Baseline and Week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
South Korea · 1 center
- Pusan National University Hospital — Busan
Identifiers
NCT: NCT07538830 · 2509-049-155