Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Randomized, Double Blinded, Placebo-controlled Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

Conditions
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Sarcopenia

Intervention / Treatment
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* Drug: Cetylpyridinium Chloride (CPC)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.5mg Cetylpyridinium Chloride (CPC)<br>1.5mg CPC will be taken daily for four weeks. | Drug: Cetylpyridinium Chloride (CPC)<br>* Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.<br>|
| Experimental: 4.5mg Cetylpyridinium Chloride (CPC)<br>4.5mg CPC will be taken daily for four weeks. | Drug: Cetylpyridinium Chloride (CPC)<br>* Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.<br>|
| Placebo Comparator: Control<br>Placebo will be taken daily for four weeks | Drug: placebo<br>* Control group takes the placebo for the same period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Cetylpyridinium chloride