Sarcopenia
Conditions
Keywords
Sarcopenia, Cetylpyridinium chloride
Brief summary
This study is to assess the impact on the prevention of sarcopenia after taking cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age of 60
Detailed description
75 people that meet the inclusion criteria on screening test are assigned to one of three groups by randomization. They take the medication for four weeks under doubleblind. Two study groups take cetylpyridinium chloride of 1.5mg, 4.5mg daily for four weeks. Control group takes the placebo for the same period. The main outcome variables are measured and compared respectively in baseline, immediately after dosing end and two weeks, four weeks after the end of administration. Finally cetylpyridinium chloride is verified whether it has a preventive effect on sarcopenia and set an appropriate dose.
Interventions
Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
DRUGplacebo
Control group takes the placebo for the same period.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M \< 7.0kg/m2, F \< 5.7kg/m2
Exclusion criteria
* History of stroke or spinal cord injury * Artificial joint * Acute disease or unstable chronic disease * Phenylketonuria * History of myocardiac infarction * Allergic contact dermatitis * History of drug/alcohol addiction, habitual smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in procollagen type III N-terminal peptide | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in transforming growth factor β1 (TGF-β1) | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in Myostatin | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in tumor necrosis factor α (TNF-α) | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in interleukin 1 (IL-1) | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in insulin like growth factor 1 (IGF-1) | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in monocyte chemoattractant protein 1 (MCP-1) | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in Skeletal muscle index | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in short physical performance battery (SPPB) | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in Grip strength | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
| Change from baseline in fatty acid binding protein 3 (FABP3) | baseline, two weeks after administration start, immediately after dosing end, two weeks after the end of administration, four weeks after the end of administration |
Countries
South Korea
Outcome results
None listed