Lactiplantibacillus plantarum LM1001 to improve muscle strength in older adults
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effects of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults.
This study will test whether taking the probiotic Lactiplantibacillus plantarum LM1001 daily for 12 weeks helps improve muscle strength in adults aged 50–84 with age-related muscle weakness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Lactomason Co., Ltd. Industry-sponsored |
| Locations | 1 site (Busan) |
| Trial ID | NCT07538830 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, single-center trial enrolling 100 adults aged 50–84 with reduced muscle mass and decreased handgrip strength. Participants will be assigned 1:1 to receive 500 mg (1.0 × 10^10 CFU/day) of Lactiplantibacillus plantarum LM1001 or a matching placebo once daily for 12 weeks. The primary outcomes are changes in isokinetic knee extension and flexion strength measured at baseline and after 12 weeks, with additional secondary physical and safety measures collected. The trial is conducted at Pusan National University Hospital and includes BMI and functional criteria for eligibility.
Who should consider this trial
Good fit: Adults aged 50–84 with BMI 18.5–30 kg/m², reduced skeletal muscle mass (≤110% of standard by BIA), decreased handgrip strength, and an SPPB score over 9 are the intended candidates.
Not a fit: People with significant acute or chronic illnesses, major gastrointestinal surgery, severe musculoskeletal or neurological disorders (including established sarcopenia), or other exclusion criteria are unlikely to benefit or be eligible for this intervention.
Why it matters
Potential benefit: If successful, the probiotic could offer a safe, non-drug option to increase muscle strength and help older adults maintain mobility and independence.
How similar studies have performed: Some small studies have linked certain probiotics to metabolic or muscle-related effects, but using Lactiplantibacillus plantarum LM1001 specifically for muscle strength is largely novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Busan
- Pusan National University Hospital — Busan, South Korea (Recruiting)
Study contacts
- Principal investigator: Myung Jun Shin, Ph.D. — Pusan National University Hospital
- Study coordinator: Yoon Ju So
- Email: yjso@lactomason.com
- Phone: +82-2-2677-0073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.