Effect of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults

NCT07538830 · tracked via the Priya Life Science South Korea tracker

Sponsor

Lactomason Co., Ltd

Phase

Not applicable

Started

2026-01-27

Last updated

2026-04-27

Condition(s) studied

Age-Related Muscle Weakness

Investigational drug(s) / intervention(s)

Lactiplantibacillus plantarum LM1001Placebo

Lactiplantibacillus plantarum LM1001: A 500 mg capsule containing Lactiplantibacillus plantarum LM1001 (1.0 x 10\^10 CFU/day).

Placebo: An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.

Study 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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

85 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Pusan National University Hospital	Busan	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07538830 on ClinicalTrials.gov ↗ ← All trials in South Korea