Effect of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults
ConditionAge-Related Muscle Weakness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorLactomason Co., Ltd.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lactiplantibacillus plantarum LM1001
Dietary supplementA 500 mg capsule containing Lactiplantibacillus plantarum LM1001 (1.0 x 10\^10 CFU/day).
Placebo
Dietary supplementAn identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Lactiplantibacillus plantarum LM1001Experimental treatment 1 intervention
Group B: Placebo controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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 122
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 123
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 124
Change in Total body fat percentage
Change from baseline in Total body fat percentage measured by BIA
Time frame
Baseline and Week 12Sponsors and contacts
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Source ClinicalTrials.gov