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Effect of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults

NCT07538830 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-27

No results posted yet for this 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.

Conditions

  • Age-Related Muscle Weakness

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.

Sponsors & Collaborators

  • Lactomason Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Myung Jun Shin, Ph.D. · Pusan National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538830 on ClinicalTrials.gov