Age-Related Muscle WeaknessNCT07538830
Effect of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults
A study testing Lactiplantibacillus plantarum LM1001 in people with Age-Related Muscle Weakness, run by Lactomason Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Muscle Weakness
- What is being tested?
- Lactiplantibacillus plantarum LM1001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
Eun Lee Lee, +82-51-240-7000, tjdfyd_eorhd@naver.com
About this study
Official title: 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.
Read more
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
- Being tested
- Lactiplantibacillus plantarum LM1001, Placebo
- Keywords
- probiotics, Lactiplantibacillus plantarum, Age-related muscle weakness, Gut-muscle axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactiplantibacillus plantarum LM1001Dietary supplement
A 500 mg capsule containing Lactiplantibacillus plantarum LM1001 (1.0 x 10^10 CFU/day).
PlaceboDietary supplement
An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (16)
Change in Muscle power
Change from baseline in Muscle power measured by Biodex at an angular velocity of 60°/s
Measured: 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)
Measured: 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
Measured: Baseline and Week 12
Change in Total body fat percentage
Change from baseline in Total body fat percentage measured by BIA
Measured: Baseline and Week 12
Change in ASM/weight × 100
Change from baseline in ASM/weight × 100 measured by BIA
Measured: 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
Measured: Baseline and Week 12
Change in Handgrip strength
Change from baseline in Handgrip strength measured by hand dynamometer
Measured: 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)
Measured: 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.
Measured: Baseline and Week 12
Change in Serum creatinine levels
Change from baseline in serum creatinine concentration
Measured: Baseline and Week 12
Change in Serum total protein levels
Change from baseline in serum total protein concentration
Measured: Baseline and Week 12
Change in Serum albumin levels
Change from baseline in serum albumin concentration
Measured: Baseline and Week 12
Change in Serum prealbumin levels
Change from baseline in serum prealbumin concentration
Measured: Baseline and Week 12
Change in Serum C-reactive protein (CRP) levels
Change from baseline in serum C-reactive protein (CRP) concentration
Measured: Baseline and Week 12
Change in Serum creatine kinase (CK) levels
Change from baseline in serum creatine kinase (CK) concentration
Measured: 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)
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start27 Jan 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the probiotic group or the placebo group and receive the assigned intervention for 12 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lactomason Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Jun Shin, Ph.D., Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538830
- Sponsor's protocol ID
- 2509-049-155
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effects of Lactiplantibacillus Plantarum LM1001 on Muscle Strength in Older Adults.
- ClinicalTrials.gov ID
- NCT07538830
- Acronym / sponsor ID
- 2509-049-155
- Conditions
- Age-Related Muscle Weakness
- Keywords
- probiotics, Lactiplantibacillus plantarum, Age-related muscle weakness, Gut-muscle axis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lactomason Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the probiotic group or the placebo group and receive the assigned intervention for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Lactiplantibacillus plantarum LM1001 | Experimental | Dietary Supplement: Lactiplantibacillus plantarum LM1001Participants 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. |
| Placebo control | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactiplantibacillus plantarum LM1001A 500 mg capsule containing Lactiplantibacillus plantarum LM1001 (1.0 x 10^10 CFU/day). | Dietary supplement | Lactiplantibacillus plantarum LM1001 |
| PlaceboAn identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate. | Dietary supplement | Placebo control |
Primary outcome
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.
16 secondary outcomes
Change in Muscle power
Time frame: Baseline and Week 12
Change in Absolute skeletal muscle mass (SM)
Time frame: Baseline and Week 12
Change in Appendicular skeletal muscle mass index (ASM/height²)
Time frame: Baseline and Week 12
Change in Total body fat percentage
Time frame: Baseline and Week 12
Change in ASM/weight × 100
Time frame: Baseline and Week 12
Change in Skeletal muscle mass index (SMM/height²)
Time frame: Baseline and Week 12
Change in Handgrip strength
Time frame: Baseline and Week 12
Change in Short Physical Performance Battery (SPPB) score
Time frame: Baseline and Week 12
Change in Timed Up and Go (TUG) test
Time frame: Baseline and Week 12
Change in Serum creatinine levels
Time frame: Baseline and Week 12
Change in Serum total protein levels
Time frame: Baseline and Week 12
Change in Serum albumin levels
Time frame: Baseline and Week 12
Change in Serum prealbumin levels
Time frame: Baseline and Week 12
Change in Serum C-reactive protein (CRP) levels
Time frame: Baseline and Week 12
Change in Serum creatine kinase (CK) levels
Time frame: Baseline and Week 12
Change in Health-related quality of life assessed by EQ-5D-5L
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Myung Jun Shin, Ph.D. principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactiplantibacillus plantarum LM1001 in people with Age-Related Muscle Weakness, run by Lactomason Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yoon Ju So (+82-2-2677-0073, yjso@lactomason.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quadriceps and hamstring muscle strength (left and right) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.