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Clinical Trial for the Evaluation of the Efficacy and Safety of KLP-KM2 on Improving Muscle Strength

A 12-week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of KLP-KM2 on Improving Muscle Strength

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009906
Enrollment
80
Registered
2024-11-07
Start date
2023-10-05
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Health Functional Food) : The detail consists of KLP-KM2 and control food, and the details are as follows. Test food: KLP-KM2 (Lactiplantibacillus plantarum KM2 fermentation culture heat treatm

Sponsors

Chung-Ang University Gwangmyeong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) A person aged 50 or older and 85 or younger 2) Those with grip strength of 36 kg for men and less than 22 kg for women 3) A person whose skeletal muscle mass measured by Inbody falls within the standard range of 100% 4) A person who has agreed to participate in this human body application test before the commencement of the human body application test and has signed a written consent form

Exclusion criteria

Exclusion criteria: 1) Persons currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, psychiatric, infectious disease and malignancy. 2) A person who has administered antibiotics within two weeks on the basis of visit 1. 3) A person who has consumed probiotics, prebiotics, synbiotics, and fermented milk and lactobacillus products continuously (more than four times a week) within two weeks of visit 1. 4) A person deemed unable to exercise due to musculoskeletal disorders, neurological diseases, cognitive impairment, etc. 5) a person with a fragile hip fracture. 6) Those with a BMI of 30 kg/m2 or higher. 7) A person who has administered systemic steroids (cortisol, etc.) or used hormone drugs (testosterone, estrogen, growth-related hormones, adrenocortical hormones, etc.) within 4 weeks of visit 1. 8) Those who have used supplements related to improving muscle strength (amino acids, creatine, etc.) or health functional foods (including vitamin D) within two weeks of visit 1 (but can participate if vitamin D has been administered without any change in dose since three months ago). 9) A person who consumes at least 140 g/week (20 degrees soju, about 2.5 bottles/week, about 2.5 cups/day) of alcohol. 10) A person who has participated in aerobics or resistance exercises continuously (three times a week) within three months of visiting 1. 11) Those whose serum creatinine exceeds 2.0 mg/dL. 12) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit. 13) Uncontrolled hypertension patients (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, and measurement criteria after stabilizing for 10 minutes). 14) Uncontrolled diabetic patients (above 180 mg/dL fasting blood sugar). 15) Those whose TSH is less than or equal to 0.1 µIU/mL or greater than or equal to 10 µIU/mL. 16) A person who is pregnant or is lactating or has a pregnancy plan during the main human body application test period. 17) A person who has participated in other interventional clinical trials (including human-applied trials) within three months of the visit 1 or who plans to participate in other interventional clinical trials (including human-applied trials) after the start of this human-applied trial. 18) A person who is sensitive or allergic to food ingredients for this human application test. 19) A person who judges that the tester is inappropriate for other reasons.

Design outcomes

Primary

MeasureTime frame
Femoral quadriceps muscle strength

Secondary

MeasureTime frame
Grip strength;ASM/Height^2;ASM/Weight*100;SMM (Skeletal Muscle Mass);Body fat ratio;SPPB (Short Physical Performance Battery);blood index;Cytokine;Microbiome

Countries

Korea, Republic of

Contacts

Public ContactKim Don-kyu

Chung-Ang University Gwangmyeong Hospital

donkim21@cau.ac.kr+82-2-2610-9224

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026