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NCT Number: NCT07538830

Effect 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.

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Key information

Conditions

Age-Related Muscle Weakness

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactiplantibacillus plantarum LM1001

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change in quadriceps and hamstring muscle strength (left and right)

    Time frame: 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.

Secondary outcomes

  1. Change in Muscle power

    Time frame: Baseline and Week 12

    Change from baseline in Muscle power measured by Biodex at an angular velocity of 60°/s

  2. Change in Absolute skeletal muscle mass (SM)

    Time frame: Baseline and Week 12

    Change from baseline in Absolute skeletal muscle mass (SM) measured by bioelectrical impedance analysis (BIA)

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

    Time frame: Baseline and Week 12

    Change from baseline in Appendicular skeletal muscle mass index (ASM/height²) measured by BIA

  4. Change in Total body fat percentage

    Time frame: Baseline and Week 12

    Change from baseline in Total body fat percentage measured by BIA

  5. Change in ASM/weight × 100

    Time frame: Baseline and Week 12

    Change from baseline in ASM/weight × 100 measured by BIA

  6. Change in Skeletal muscle mass index (SMM/height²)

    Time frame: Baseline and Week 12

    Change from baseline in Skeletal muscle mass index (SMM/height²) measured by BIA

  7. Change in Handgrip strength

    Time frame: Baseline and Week 12

    Change from baseline in Handgrip strength measured by hand dynamometer

  8. Change in Short Physical Performance Battery (SPPB) score

    Time frame: Baseline and Week 12

    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)

  9. Change in Timed Up and Go (TUG) test

    Time frame: Baseline and Week 12

    Change from baseline in functional mobility based on the time taken to stand, walk, turn, and return to a seated position.

  10. Change in Serum creatinine levels

    Time frame: Baseline and Week 12

    Change from baseline in serum creatinine concentration

  11. Change in Serum total protein levels

    Time frame: Baseline and Week 12

    Change from baseline in serum total protein concentration

  12. Change in Serum albumin levels

    Time frame: Baseline and Week 12

    Change from baseline in serum albumin concentration

  13. Change in Serum prealbumin levels

    Time frame: Baseline and Week 12

    Change from baseline in serum prealbumin concentration

  14. Change in Serum C-reactive protein (CRP) levels

    Time frame: Baseline and Week 12

    Change from baseline in serum C-reactive protein (CRP) concentration

  15. Change in Serum creatine kinase (CK) levels

    Time frame: Baseline and Week 12

    Change from baseline in serum creatine kinase (CK) concentration

  16. Change in Health-related quality of life assessed by EQ-5D-5L

    Time frame: Baseline and Week 12

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eunju Lim

CONTACT

[email protected]

+82-55-360-5988

Yoon Ju So

CONTACT

[email protected]

+82-2-2677-0073

Sponsors and collaborators

Lead sponsor

Lactomason Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effects of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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