Effect of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults

NCT07538830 | Recruiting

• 1 other identifier: 2509-049-155
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

probiotics; Lactiplantibacillus plantarum; Age-related muscle weakness; Gut-muscle axis

Outcome Measures

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.

  Baseline and Week 12

Secondary Outcomes (16)

• Change in Muscle power

  Baseline and Week 12

• Change in Absolute skeletal muscle mass (SM)

  Baseline and Week 12

• Change in Appendicular skeletal muscle mass index (ASM/height²)

  Baseline and Week 12

• Change in Total body fat percentage

  Baseline and Week 12

• Change in ASM/weight × 100

  Baseline and Week 12

Study Arms (2)

Lactiplantibacillus plantarum LM1001

EXPERIMENTAL

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

Placebo control

PLACEBO COMPARATOR

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

Interventions

Lactiplantibacillus plantarum LM1001 DIETARY_SUPPLEMENT

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

Lactiplantibacillus plantarum LM1001

Placebo DIETARY_SUPPLEMENT

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

Placebo control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lactomason Co., Ltd.: lead

Study Sites (1)

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Study Officials

• Myung Jun Shin, Ph.D.

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoon Ju So

CONTACT

+82-2-2677-0073; yjso@lactomason.com

Eunju Lim

CONTACT

+82-55-360-5988; lit5540@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care provider, investigators, and outcome assessors are blinded to the group allocation. The investigational product and placebo are identical in appearance, taste, and packaging.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either the probiotic group or the placebo group and receive the assigned intervention for 12 weeks.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)