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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.5mg Cetylpyridinium Chloride (CPC) | Experimental | 1.5mg CPC will be taken daily for four weeks. |
|
| 4.5mg Cetylpyridinium Chloride (CPC) | Experimental | 4.5mg CPC will be taken daily for four weeks. |
|
| Control | Placebo Comparator | Placebo will be taken daily for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetylpyridinium Chloride (CPC) | Drug | Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 transforming growth factor β1 (TGF-β1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University College of Medicine | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19657557 | Background | Pahor M, Manini T, Cesari M. Sarcopenia: clinical evaluation, biological markers and other evaluation tools. J Nutr Health Aging. 2009 Oct;13(8):724-8. doi: 10.1007/s12603-009-0204-9. | |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002594 | Cetylpyridinium |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | Control group takes the placebo for the same period. |
|
| 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 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 |
| 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 |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |