Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy

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 presarcopenia over the age of 60.

Detailed Description
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65 people that meet the inclusion criteria on screening test are assigned to one of five groups by randomization. They take the medication for two weeks under double-blind. Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two 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 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: An Exploratory Pilot Study

Conditions
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Sarcopenia

Intervention / Treatment
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* Drug: cetylpyridinium chloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presarcopenia A. Reduced skeletal muscle mass (ASM/height2) M < 7.0kg/m2, F < 5.7kg/m2 B. Normal grip strength M ≥ 26kg, F ≥ 18kg C. Normal physical performance Gait speed > 0.8m/s Community dwelling 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<br>Cetylpyridinium chloride of 1.5mg will be taken daily for two weeks. | Drug: cetylpyridinium chloride<br>* Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.<br>* Other names: CEGATON Troche;|
| Experimental: 3mg Cetylpyridinium Chloride<br>Cetylpyridinium chloride of 3mg will be taken daily for two weeks. | Drug: cetylpyridinium chloride<br>* Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.<br>* Other names: CEGATON Troche;|
| Experimental: 4.5mg Cetylpyridinium Chloride<br>Cetylpyridinium chloride of 4.5mg will be taken daily for two weeks. | Drug: cetylpyridinium chloride<br>* Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.<br>* Other names: CEGATON Troche;|
| Experimental: 6mg Cetylpyridinium Chloride<br>Cetylpyridinium chloride of 6mg will be taken daily for two weeks. | Drug: cetylpyridinium chloride<br>* Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.<br>* Other names: CEGATON Troche;|
| Placebo Comparator: Control<br>Placebo will be taken daily for two 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, immediately after dosing end, two weeks after the end of administration | 
| Change from baseline in myostatin |  | baseline, immediately after dosing end, two weeks after the end of administration | 
| Change from baseline in TNF-α |  | baseline, immediately after dosing end, two weeks after the end of administration | 
| Change from baseline in IL-6 |  | baseline, immediately after dosing end, two weeks after the end of administration | 
| Change from baseline in urinary creatinine |  | baseline, immediately after dosing end, two weeks after the end of administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in CRP |  | baseline, immediately after dosing end, two weeks after the end of administration | 
| Change from baseline in Hemoblobin |  | baseline, immediately after dosing end, two weeks after the end of administration | 
| Change from baseline in Albumin |  | baseline, immediately after dosing end, two weeks after the end of administration | 
| Change from baseline in Vitamin D |  | baseline, immediately after dosing end, two 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