Effect of Lactiplantibacillus Plantarum LM1001 on 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.

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.

Study Overview

• Status: Recruiting
• Conditions: Age-Related Muscle Weakness
• Intervention / Treatment: Dietary supplement: Lactiplantibacillus plantarum LM1001; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoon Ju So; Phone Number: +82-2-2677-0073; Email: yjso@lactomason.com
• Study Contact Backup: Name: Eunju Lim; Phone Number: +82-55-360-5988; Email: lit5540@naver.com

Study Locations

• South Korea
  • Busan, South Korea, 49241
    • Recruiting
    • Pusan National University Hospital
    • Contact: Eun Lee Lee; Phone Number: +82-51-240-7000; Email: tjdfyd_eorhd@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control; Participants in this arm will take one placebo capsule (containing processed starch, etc.) identical in appearance to the test product, once daily in the morning before breakfast with sufficient water throughout the study period.	Dietary supplement: Placebo; An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.
Experimental: Lactiplantibacillus plantarum LM1001; Participants in this arm will take one capsule containing 500 mg of Lactiplantibacillus plantarum LM1001 (1.0 x 10^10 CFU/day) once daily, once daily in the morning before breakfast with sufficient water throughout the study period.	Dietary supplement: Lactiplantibacillus plantarum LM1001; A 500 mg capsule containing Lactiplantibacillus plantarum LM1001 (1.0 x 10^10 CFU/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle power	Change from baseline in Muscle power measured by Biodex at an angular velocity of 60°/s	Baseline and Week 12
Change in Absolute skeletal muscle mass (SM)	Change from baseline in Absolute skeletal muscle mass (SM) measured by bioelectrical impedance analysis (BIA)	Baseline and Week 12
Change in Appendicular skeletal muscle mass index (ASM/height²)	Change from baseline in Appendicular skeletal muscle mass index (ASM/height²) measured by BIA	Baseline and Week 12
Change in Total body fat percentage	Change from baseline in Total body fat percentage measured by BIA	Baseline and Week 12
Change in ASM/weight × 100	Change from baseline in ASM/weight × 100 measured by BIA	Baseline and Week 12
Change in Skeletal muscle mass index (SMM/height²)	Change from baseline in Skeletal muscle mass index (SMM/height²) measured by BIA	Baseline and Week 12
Change in Handgrip strength	Change from baseline in Handgrip strength measured by hand dynamometer	Baseline and Week 12
Change in Short Physical Performance Battery (SPPB) score	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)	Baseline and Week 12
Change in Timed Up and Go (TUG) test	Change from baseline in functional mobility based on the time taken to stand, walk, turn, and return to a seated position.	Baseline and Week 12
Change in Serum creatinine levels	Change from baseline in serum creatinine concentration	Baseline and Week 12
Change in Serum total protein levels	Change from baseline in serum total protein concentration	Baseline and Week 12
Change in Serum albumin levels	Change from baseline in serum albumin concentration	Baseline and Week 12
Change in Serum prealbumin levels	Change from baseline in serum prealbumin concentration	Baseline and Week 12
Change in Serum C-reactive protein (CRP) levels	Change from baseline in serum C-reactive protein (CRP) concentration	Baseline and Week 12
Change in Serum creatine kinase (CK) levels	Change from baseline in serum creatine kinase (CK) concentration	Baseline and Week 12
Change in Health-related quality of life assessed by EQ-5D-5L	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)	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Lactomason Co., Ltd.
• Investigators: Principal Investigator: Myung Jun Shin, Ph.D., Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: probiotics; Lactiplantibacillus plantarum; Age-related muscle weakness; Gut-muscle axis
• Other Study ID Numbers: 2509-049-155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No